FDA Adverse Event
Injury
Summary report: N
PRIMARY LEFT HIP
MDR report key: 2202454
·
Received August 5, 2011
Report
- Report Number
- 2249697-2011-01171
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- June 16, 1994
- Report Date
- July 15, 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 IT BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PT HAD PRIMARY LEFT HIP TOTAL HIP REPLACEMENT IN 1994 AND REQUIRED A REVISION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIMARY LEFT HIP | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other| R |