FDA Adverse Event
Injury
Summary report: N
UKNOWN RIGHT TOTAL HIP REPLACEMENT
MDR report key: 2151540
·
Received June 28, 2011
Report
- Report Number
- 2249697-2011-00960
- Event Type
- Injury
- Date Received
- June 28, 2011
- Date of Event
- August 30, 1991
- Report Date
- June 6, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT HAS BEEN IN PAIN AND ON PAIN MEDICATION SINCE THE REPLACEMENT SURGERY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UKNOWN RIGHT TOTAL HIP REPLACEMENT | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other |