FDA Adverse Event
Injury
Summary report: N
HOWMEDICA AUFRANC TURNER STEM
MDR report key: 1772134
·
Received July 22, 2010
Report
- Report Number
- 2249697-2010-00874
- Event Type
- Injury
- Date Received
- July 22, 2010
- Date of Event
- June 16, 2010
- Report Date
- June 29, 2010
- 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFO WAS PROVIDED BY STRYKER ORTHOPAEDICS' CLINICAL AFFAIRS DEPT. NO ADD'L INFO IS AVAILABLE AT THIS TIME. ADD'L F/U INFO MAY BE OBTAINED BY THE CLINICAL AFFAIRS AS IT BECOMES AVAILABLE. THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
SITE INDICATED THAT A SUBJECT BEING ENROLLED IN THE TRIDENT TRITANIUM ACETABULAR SHELL REVISION STUDY, (B)(4), HAD PREVIOUS STRYKER IMPLANTS (ORIGINAL IMPLANT LISTED AS 1986). PROGRESSIVE PAIN AND RADIOGRAPHIC EVIDENCE OF LOOSENING WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOWMEDICA AUFRANC TURNER STEM | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other| R |