FDA Adverse Event
Summary report: N
BIRMINGHAM HIP RESURFACING ACETABULAR CUP W/ IMPACTOR
MDR report key: 2973642
·
Received February 12, 2013
Report
- Report Number
- 2973642
- Date Received
- February 12, 2013
- Date of Event
- February 4, 2013
- Report Date
- February 12, 2013
- Manufacturer
- SMITH & NEPHEW
- Product Code
- JDI
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
ORTHOPEDIC SURGEON CUTTING THE WIRES THAT ARE ATTACHED TO THE ACETABULAR METAL CUP IMPLANT AND THE POLYETHELINE DISC. THE WIRE IS LOOPED THROUGH IN 3 PLACES AND IS CUT AT EACH LOOP WITH WIRE CUTTERS. THE WIRE CUTTERS DID NOT "SNAP DOWN" OR 'CLICK" TO INDICATE THAT THE WIRE HAD BEEN CUT. THE WIRE WAS THEN CUT AGAIN. DURING THE POST OP XRAY A FOREIGN BODY WAS NOTICED. THE PATIENT THEN RETURNED TO SURGERY THE NEXT DAY TO HAVE A 1CM PIECE OF WIRE REMOVED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RIGHT BIRMINGHAM HIP RESURFACING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61978 | BIRMINGHAM HIP RESURFACING ACETABULAR CUP W/ IMPACTOR | PROSTHESIS,HIP, SEMI-CONSTRAINED, METAL/METAL | JDI | SMITH & NEPHEW | * | 11HW33934 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | CATE THAT THE WIRE WAS CUT| WIRE CUTTERS (THIS IS A RESUABLE/WEAR ITEM): THE| NO OTHER THERAPIES| WIRE CUTTER DID NOT "SNAP DOWN" OR "CLICK" TO INDI |