FDA Adverse Event
Malfunction
Summary report: N
NEXGEN RHK ARTICULAR SURFACE PROVISIONAL
MDR report key: 2152379
·
Received June 28, 2011
Report
- Report Number
- 1822565-2011-01528
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Date of Event
- May 18, 2011
- Report Date
- May 31, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: GIVEN THE AGE AND CONDITION OF THE DEVICE IT APPEARS NORMAL WEAR AND TEAR ARE THE CAUSE FOR THE REPORTED ISSUE. AS RETURNED THE PROVISIONAL ARTICULAR SURFACE HAS A PIECE FRACTURED OFF THE DEVICE. THE DEVICE HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 5 YEARS AND SHOWS NICKS AND DINGS FROM AN UNKNOWN AMOUNT OF USE. THE DEVICE MEETS SPECIFICATIONS AS MEASURED.
Description of Event or Problem · 1
IT IS REPORTED THAT WHEN THE SURGEON WAS REMOVING THE TRIAL SURFACE, IT FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN RHK ARTICULAR SURFACE PROVISIONAL | JWH | ZIMMER, INC. | 60458785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |