FDA Adverse Event
Injury
Summary report: N
RESTORATION ADM. INSERT
MDR report key: 2562728
·
Received May 2, 2012
Report
- Report Number
- 9616680-2012-00321
- Event Type
- Injury
- Date Received
- May 2, 2012
- Date of Event
- March 7, 2012
- Report Date
- April 10, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K072020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ASSOCIATED DEVICE: 28MM +40 V40 TAPER VIT HEAD, CATALOG # 62060-5-228, LOT # 160792. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE SURGEON AT THE HOSPITAL ALLEGED THAT "HE PERFORMED A REVISION SURGERY BECAUSE THE PT FELL AND HAD A DISLOCATION OF ADM CUP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORATION ADM. INSERT | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | G2876884 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |