FDA Adverse Event
Injury
Summary report: N
UNKNOWN SCREW
MDR report key: 2232382
·
Received August 26, 2011
Report
- Report Number
- 9610622-2011-00402
- Event Type
- Injury
- Date Received
- August 26, 2011
- Date of Event
- November 27, 2009
- Report Date
- August 4, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HWC
- 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
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "WHEN THE PATIENT TAKES A STEP HE HAS EXTREME PAIN BUT NOT ALWAYS IN THE SAME SPOT. THE PATIENT HAD ROD AND SCREWS PUT INTO HIS HIP AFTER A FALL. WHEN THE SCREW LOOSENED SURGEON RECOMMENDED A TOTAL HIP REPLACEMENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN SCREW | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Other| R |