FDA Adverse Event
Injury
Summary report: N
HSS
MDR report key: 112095
·
Received July 31, 1997
Report
- Report Number
- 2436878-1997-00001
- Event Type
- Injury
- Date Received
- July 31, 1997
- Date of Event
- July 2, 1997
- Manufacturer
- HOSP FOR SPECIAL SURGERY BIOMECHANICS DEPT
- Product Code
- KWJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON 12/30/91, THE SUBJECT TOTAL ELBOW REPLACEMENT WAS IMPLANTED. ON FOLLOW-UP X-RAY (DATED 5/13/97), THE AXLE THAT HOLDS THE ULNAR AND HUMERAL COMPONENTS TOGETHER WAS SHOWN TO BE PARTIALLY DISENGAGED. ON 5/14/97, THE INITIAL REPORTER NOTIFIED CO. ON 7/2/97, THE PROBLEM WAS CORRECTED BY REVISION SURGERY. THE CLIP THAT HOLDS THE AXLE IN PLACE, AS WELL AS THE HUMERAL AND ULNAR COMPONENTS WERE LEFT IN SITU. THE AXLE, PLASTIC BUSHING AND PLASTIC BEARING WERE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HSS Implant | TOTAL ELBOW REPLACEMENT | KWJ | HOSP FOR SPECIAL SURGERY BIOMECHANICS DEPT | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization| R |