FDA Adverse Event
Injury
Summary report: N
UNKNOWN LEFT REJUVENATE/ABGII HIP
MDR report key: 2801350
·
Received October 17, 2012
Report
- Report Number
- 2249697-2012-01885
- Event Type
- Injury
- Date Received
- October 17, 2012
- Date of Event
- December 14, 2009
- Report Date
- September 27, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, HOWEVER BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD BILATERAL HIP SURGERIES ON (B)(6) 2009. SINCE THEN, PATIENT COMPLAINS OF ON AND OFF PAIN IN BOTH HIPS. MRI AND TESTING HAVE SHOWN FLUID BUILD UP IN BOTH HIP JOINTS. THE TOXIC LIQUID HAS CAUSED THE BONE TO DETERIORATE. PATIENT WILL UNDERGO ASPIRATION OF BOTH HIPS NEXT WEEK. HIS SURGEON HAS SCHEDULED HIM FOR REVISION SURGERY ON (B)(6) 2012 FOR BOTH HIPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN LEFT REJUVENATE/ABGII HIP | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |