FDA Adverse Event
Injury
Summary report: N
TRIDENT PSL HA CLUSTER 56MM
MDR report key: 1810079
·
Received August 16, 2010
Report
- Report Number
- 2249697-2010-01103
- Event Type
- Injury
- Date Received
- August 16, 2010
- Date of Event
- July 26, 2010
- Report Date
- July 26, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K983382
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "THE ABOVE IMPLANTS WERE EXPLANTED DUE TO PAIN AND A REACTIVE RESPONSE TO MATERIALS. THE (B)(4) ACCOLADE #2 STEM (LOT 11658104) WAS FOUND TO BE WELL FIXED AND WAS LEFT IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT PSL HA CLUSTER 56MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | 26713702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other| R | 6.5 CANCELLOUS BONE SCREW 30MM, CAT # 2030-6530-1,| LOT # 10946202| TRIDENT ALUMINA INSERT, CAT # 625-0T-32F,| LOT # 27073202| ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK,| CAT # 6565-0-132, LOT # 1179603 |