—#114616

Product

SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K060581
Affected lot / code info: Product Code: 157215180 and Lot codes: 116897, 126366, A63GP1000, A63GPA000, AP2BD1000, B19CL1000, B19CLA000, B19CLC000, B3DE71000, B3DE7A000, B5CA41000, C1PDC1000, C4YBG1000, C4YBGB, CB1EX1000, CC5JR1000, CH1AC1000, CH7EG1000, CL5PF1000, DD3BT1000, DD3BTA000, DH9JW1000, E1KKA1000, EC8DY1000, ET4FH1000, FB8RA1, FG9KV1, X2HD31000, X2HD41000, X2HD4B000, X2HD4C000, X2HD4D000, X2HD51000, X2HD5A000, X5REB1000, X5REBB000, XY7F71000, YA6GS1000, YG3DE1000, YH8AK1000, YH8AKA000, and Z5VAP1000.

Why it was recalled

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Root cause (FDA determination)

Device Design

Action the firm took

Deputh Orthopaedics sent an Urgent Information - Medical Device Recall Notice dated December , 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The notification letter instructed consignees to please cease further distribution or use of products immediately. The purpose of the communication was to inform them of this recall and request acknowledgement of receipt of this letter by their facility. Reconciliation forms should be returned to your DePuy Sales Representative or faxed to the following Fax Number: 574-371-4939. For questions regarding this recall call 574-267-8143.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

Timeline

Recall initiated: 2012-12-03
Posted by FDA: 2012-12-20
Terminated: 2013-11-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114616. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.