FDA Adverse Event
Injury
Summary report: N
RESTORATION ADM X3 INS 28/54
MDR report key: 2600488
·
Received May 31, 2012
Report
- Report Number
- 9616680-2012-00406
- Event Type
- Injury
- Date Received
- May 31, 2012
- Date of Event
- May 9, 2012
- Report Date
- May 9, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K093644
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBER AND LOT CODE OF OTHER DEVICE LISTED IN THIS REPORT: DESCRIPTION: C-TAPER 28 POSTERIOR HEAD, CAT #06-2800, LOT #MJND5W. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S EXPERIENCE. WHEN THE INVESTIGATION IS COMPLETED, THE RESULT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT HAD A RIGHT TOTAL HIP REPLACEMENT. HEAD LINER EXCHANGE DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORATION ADM X3 INS 28/54 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 38395301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |