FDA Adverse Event
Injury
Summary report: N
UNK HYLAMER LINER
MDR report key: 246727
·
Received October 29, 1999
Report
- Report Number
- 1818910-1999-00191
- Event Type
- Injury
- Date Received
- October 29, 1999
- Date of Event
- April 27, 1999
- Report Date
- October 29, 1999
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JDI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THIS PT WAS REVISED DUE TO HYLAMER WEAR. PT'S HEIGHT IS 5' 0". TH SHELL WAS NOT REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK HYLAMER LINER Implant | TOTAL HIP PROSTHESIS | JDI | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |