FDA Adverse Event
Malfunction
Summary report: N
TRIDENT PSL HA CLUSTER 56MM
MDR report key: 2414751
·
Received December 9, 2011
Report
- Report Number
- 2249697-2011-01746
- Event Type
- Malfunction
- Date Received
- December 9, 2011
- Date of Event
- June 7, 2011
- Report Date
- September 27, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K983382
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION PROVIDED BY STRYKER ORTHOPAEDICS CLINICAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL FOLLOW-UP INFORMATION MAY BE OBTAINED BY THE CLINICAL AFFAIRS AS IT BECOMES AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
SUBJECT REPORTED SNAPPING AND CLICKING OF RIGHT HIP ON (B)(6) 2011 OFFICE VISIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT PSL HA CLUSTER 56MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | MJTPTM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |