FDA Adverse Event
Injury
Summary report: N
CORMET RESURFACING
MDR report key: 3131081
·
Received May 22, 2013
Report
- Report Number
- 9614209-2013-00016
- Event Type
- Injury
- Date Received
- May 22, 2013
- Date of Event
- September 4, 2012
- Report Date
- December 6, 2012
- Manufacturer
- CORIN LTD.
- Product Code
- NXT
- PMA / PMN Number
- K082525
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BATCH MANUFACTURING RECORDS AND CASE NOTES TO BE REVIEWED. CASE REPORTED DUE TO CORMET CUP, HOWEVER, CEMENTLESS HEAD DEVICE USED NOT AVAILABLE IN THE USA. THIS IS OUTSIDE USA.
Description of Event or Problem · 1
CORMET REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227727 | CORMET RESURFACING | NXT METAL ON METAL RE-SURFACING | NXT | CORIN LTD. | LHGL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization | LOT LGQX| ASSOCIATED CORMET RESURFACING HEAD: CODE (B)(4) |