FDA Adverse Event
Injury
Summary report: N
UNKNOWN HIP STEM
MDR report key: 2885004
·
Received December 12, 2012
Report
- Report Number
- 2249697-2012-02626
- Event Type
- Injury
- Date Received
- December 12, 2012
- Date of Event
- September 1, 2010
- Report Date
- November 19, 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
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. DEVICE INFORMATION HAS NOT BEEN PROVIDED AT THIS TIME. INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT REPORTED DEVICE MAY BE EITHER REJUVENATE OR ABGII. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT: PATIENT IS EXPERIENCING PAIN. PATIENT STATES, HE HAS LITTLE TO NO SWELLING. HE HAD BLOOD WORK DONE. THE SURGEON STATES THAT HE HAS ELEVATED BLOOD LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN HIP STEM | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other |