FDA Adverse Event
Injury
Summary report: N
OSTEOTICS TRIDENT SHELL SIZE 54
MDR report key: 1163105
·
Received September 16, 2008
Report
- Report Number
- 2249697-2008-00274
- Event Type
- Injury
- Date Received
- September 16, 2008
- Date of Event
- August 20, 2008
- Report Date
- August 20, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED DUE TO PRIOR AGREEMENT BETWEEN THE DR. AND STRYKER. NO EVAL WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT "IMPLANTED WAS REMOVED FOR REVISION OF ACETABULAR SHELL DUE TO ASEPTIC LOOSENING".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSTEOTICS TRIDENT SHELL SIZE 54 | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |