FDA Adverse Event
Injury
Summary report: N
PINN MAR +4 10D 60ODX28ID
MDR report key: 405748
·
Received July 19, 2002
Report
- Report Number
- 1818910-2002-00395
- Event Type
- Injury
- Date Received
- July 19, 2002
- Date of Event
- June 21, 2002
- Report Date
- July 19, 2002
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE 1217-22-060 CUP WAS IMPLANTED AND THE SURGEON TRIED A 1219-28-460 LINER. IT WAS NOT SEAT. HE TRIED A 1219-28-160 LINER AND IT WOULD NOT SEAT. HE CHANGED THE CUP TO A 1217-22-062 AND USED A 1219-28-462 LINER. THE PROCEDURE WAS EXTENDED 35 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINN MAR +4 10D 60ODX28ID | TOTAL HIP PROSTHESIS | LPH | DEPUY ORTHOPAEDICS, INC. | NA | VL4JL1024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |