FDA Adverse Event
Injury
Summary report: N
TRIDENT PSL HA SOLID BACK 52MM
MDR report key: 3171348
·
Received June 14, 2013
Report
- Report Number
- 0002249697-2013-01921
- Event Type
- Injury
- Date Received
- June 14, 2013
- Date of Event
- May 14, 2013
- Report Date
- May 14, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K983382
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 1
THIS EVENT IS RELATED TO VOLUNTARY RECALL RA 2012-067. THIS RECALL WAS INITIATED DUE TO THE POTENTIAL RISKS ASSOCIATED WITH MODULAR NECK STEMS.
Description of Event or Problem · 1
STAGE I REVISION WITH A REJUVENATE STEM. TREATED AS AN INFECTION. BONE SCAN REVEALED CUP WAS LOOSE SURGEON NOT CLEAR AS TO REASON.
Description of Event or Problem · 1
STAGE I REVISION WITH A REJUVENATE STEM. TREATED AS AN INFECTION. BONE SCAN REVEALED CUP WAS LOOSE SURGEON NOT CLEAR AS TO REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271928 | TRIDENT PSL HA SOLID BACK 52MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS-MAHWAH | 33661601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other| R |