FDA Adverse Event
Injury
Summary report: N
UHR BIPOLAR 26X53MM
MDR report key: 1839696
·
Received September 16, 2010
Report
- Report Number
- 2249697-2010-01223
- Event Type
- Injury
- Date Received
- September 16, 2010
- Date of Event
- August 20, 2010
- Report Date
- August 23, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWL
- PMA / PMN Number
- K800207
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR # 2249697-2010-01224.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "REVISED THE UH1 BIPOLAR AND 06-2605 HEAD DUE TO FAILED ENDO PROSTHESIS. THE INSERT LISTED ON THE PER, ITEM (B)(4), LOT MJL453 WAS IMPLANTED AND THEN SURGEON DECIDED TO REPOSITION AND REMOVE AND IMPLANT A DIFFERENT INSERT, SO THIS ONE WAS FROM THIS REVISION CASE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UHR BIPOLAR 26X53MM | IMPLANT | KWL | STRYKER ORTHOPAEDICS MAHWAH | NA | ARPMHE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |