FDA Adverse Event
Injury
Summary report: N
1043534-2012-01164
MDR report key: 2755967
·
Received September 24, 2012
Report
- Report Number
- 1043534-2012-01164
- Event Type
- Injury
- Date Received
- September 24, 2012
- Date of Event
- August 11, 2010
- Report Date
- September 19, 2012
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- MRA
- PMA / PMN Number
- P030027
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER FDA, REOPENED FILE AS A REPORTABLE MALFUNCTION IN ORDER TO REPORT AS PART OF A RETROSPECTIVE REVIEW OF CERAMIC HEADS. THIS IS THE SAME EVENT AS 1043534-2012-01162, 01163, 01165.
Additional Manufacturer Narrative · 1
CONCLUSION: USER ERROR CONTRIBUTED TO EVENT. OTHER: MISAPPLICATION/MISUSE OF DEVICE.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO MULTIPLE DISLOCATIONS. THE ORIGINAL CUP WHICH HAD BEEN IMPLANTED BY A DIFFERENT SURGEON, APPEARED TO HAVE BEEN IMPLANTED IN A RETROVERTED POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRA | WRIGHT MEDICAL TECHNOLOGY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |