FDA Adverse Event
Injury
Summary report: N
UNKNOWN - RIGHT HIP REPLACEMENT
MDR report key: 2232478
·
Received August 25, 2011
Report
- Report Number
- 2249697-2011-01243
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- November 27, 2009
- Report Date
- August 4, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWY
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "WHEN THE PT TAKES A STEP HE HAS EXTREME PAIN BUT NOT ALWAYS IN THE SAME SPOT. HE IS NOW IN CONSIDERABLE PAIN AND CANNOT CONTINUE HIS PREVIOUS ACTIVE LIFESTYLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN - RIGHT HIP REPLACEMENT | IMPLANT | KWY | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Other| R |