FDA Adverse Event
Injury
Summary report: N
ZIMMER
MDR report key: 93066
·
Received May 21, 1997
Report
- Report Number
- 39747-1997-00001
- Event Type
- Injury
- Date Received
- May 21, 1997
- Date of Event
- March 25, 1997
- Report Date
- May 14, 1997
- Manufacturer
- ZIMMER, INC.
- Product Code
- LOD
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HIP REVISION, FEMORAL STEM, PRE-OP DIAGNOSIS ASEPTIC LOOSENING LEFT HIP, OTHER DEVICE USED CENTRALIGN #4 STEM FEMORAL HEAD (9800-04 AND 9026-29) (LOT #64241800 AND #63979100). EXPLANTED ITEMS WERE SENT TO PATHOLOGY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER Implant | DOUGH TYPE BONE CEMENT | LOD | ZIMMER, INC. | * | 63843900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention | UNK. |