FDA Adverse Event
Injury
Summary report: N
ZMR HIP SYSTEM FEMORAL STEM REVISION TAPER
MDR report key: 1020625
·
Received March 28, 2008
Report
- Report Number
- 1822565-2008-00138
- Event Type
- Injury
- Date Received
- March 28, 2008
- Date of Event
- January 1, 2008
- Report Date
- February 8, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION - THE TAPER STEM HAS FRACTURED AT THE JUNCTION WITH THE CONE BODY. THE PACKAGE INSERT CONTAINS STATEMENTS WARNING THAT DEVICE FRACTURES MAY OCCUR WHERE EXCESSIVE PT WEIGHT, EXCESSIVE PT ACTIVITY, OR LACK OF PROXIMAL SUPPORT OF THE BODY ARE INVOLVED. NOT ALL OF THESE FACTORS ARE KNOWN FOR THIS CASE. THERE IS NO DEFINITIVE INDICATION THAT DESIGN OR MANUFACTURE OF THE DEVICE CONTRIBUTED TO THE OUTCOME DESCRIBED HERE. RISK MANAGEMENT ACTIVITY HAS BEEN INITIATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THIS REPORT WILL BE AMENDED.
Description of Event or Problem · 1
IT IS REPORTED THAT THE DEVICE WERE IMPLANTED IN 2001. POST-OP, THE DEVICE FRACTURED AT THE BODY STEM JUNCTION. THE DEVICE WAS REVISED IN 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZMR HIP SYSTEM FEMORAL STEM REVISION TAPER | HIP PROSTHESIS | KWY | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| R | ZMR HIP SYSTEM FEMORAL BODY REVISION TAPER LOT#UNK| CATALOG #00999209545 |