FDA Adverse Event
Injury
Summary report: N
78/74 A/P L FEMORAL
MDR report key: 260842
·
Received February 3, 2000
Report
- Report Number
- 1818910-1999-00282
- Event Type
- Injury
- Date Received
- February 3, 2000
- Date of Event
- November 17, 1999
- Report Date
- February 3, 2000
- Manufacturer
- DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC.
- Product Code
- HSA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
MEDWATCH FORM RECEIVED FROM HOSPITAL ON 12/28/1999 AND FAXED TO WARSAW. PT RECEIVED TOTAL LEFT KNEE IN 1995. X-RAYS REVEALED WORN POLY AND METAL ON METAL. REVISION DONE IN 1999, AND A CRACKED FEMORAL COMPONENT WAS DISCOVERED. ONLY ONE PART NUMBER WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 78/74 A/P L FEMORAL | TOTAL KNEE PROSTHESIS | HSA | DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC. | NA | 837DF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |