FDA Adverse Event
Injury
Summary report: N
RESTORATION ADM X3 INS 28/48
MDR report key: 2850826
·
Received November 21, 2012
Report
- Report Number
- 9616680-2012-01161
- Event Type
- Injury
- Date Received
- November 21, 2012
- Date of Event
- October 30, 2012
- Report Date
- October 31, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A DELTA V-40 CERAMIC HEAD, CAT # 6570-0-028, LOT # UNK; WAS ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S EXPERIENCE. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS EXPERIENCING HIP PAIN. REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORATION ADM X3 INS 28/48 | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other| R |