FDA Adverse Event
Injury
Summary report: N
KRH BUSHING STANDARD
MDR report key: 2182444
·
Received July 19, 2011
Report
- Report Number
- 2249697-2011-01082
- Event Type
- Injury
- Date Received
- July 19, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 28, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K792089
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE DOCTOR/PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "REVISED POLY COMPONENTS. DECIDED TO REPLACE THE FEMUR WITH A GMRS FEMUR SO THEY COULD UTILIZE THICKER BUSHINGS. ORIGINAL BUSHINGS WERE WORN OUT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KRH BUSHING STANDARD | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | TBB8709 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Required Intervention |