FDA Adverse Event
Malfunction
Summary report: N
TRABECULAR METAL REVERSE LINER IMPACTOR
MDR report key: 1934466
·
Received November 23, 2010
Report
- Report Number
- 1822565-2010-01172
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- October 14, 2010
- Report Date
- October 15, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: IT IS LIKELY THE FRACTURE OCCURRED DUE TO HIGH, REPEATED IMPACTION FORCES. THE DESIGN HAS BEEN MODIFIED SINCE THE MANUFACTURE OF THIS LOT TO CHANGE THE MATERIAL IN ORDER TO REDUCE THE OCCURRENCE OF THIS TYPE OF FAILURE. EVALUATION: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION AT THE TIME OF MANUFACTURE. AS RETURNED, THE PIN ON THE IMPACTOR HAS FRACTURED AT ITS BASE. THE DEVICE HAD A POTENTIAL FIELD AGE OF BETWEEN 2 AND 3 YEARS AT THE TIME OF FAILURE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE IMPACTOR FRACTURED DURING USE AND THE FRACTURED PORTION HAD TO BE RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRABECULAR METAL REVERSE LINER IMPACTOR | SHOULDER INSTRUMENTATION | HWA | ZIMMER, INC. | 60870480 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |