FDA Adverse Event
Injury
Summary report: N
TRIDENT PSL HA CLUSTER 48MM
MDR report key: 2221183
·
Received August 17, 2011
Report
- Report Number
- 2249697-2011-01198
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- July 23, 2011
- Report Date
- July 23, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K983382
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PATIENT CAME TO THE OFFICE ON (B)(6) 2011 COMPLAINING OF HIP PAIN. UPON X-RAY, CUP SHOWN TO BE LOOSENED AND MIGRATING SO REVISION WAS SCHEDULED. THE PATIENT DID TAKE A FALL IN MARCH. CUP CAME OUT EASILY DURING REVISION. NO ON GROWTH WAS SEEN. PATIENT REQUESTED IMPLANTS. NO OTHER INFORMATION AVAILABLE FOR THIS REPORT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT PSL HA CLUSTER 48MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | MJRN3P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other| R |