FDA Adverse Event
Injury
Summary report: N
COCR HEAD 54MM/20.25MM - STERILE
MDR report key: 2151593
·
Received June 29, 2011
Report
- Report Number
- 1719045-2011-00325
- Event Type
- Injury
- Date Received
- June 29, 2011
- Report Date
- June 9, 2011
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HSD
- PMA / PMN Number
- K072578
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED. INVESTIGATION IS ONGOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MFG RECORDS HAS BEEN REQUESTED.
Description of Event or Problem · 1
SURGEON PERFORMED REVISION SURGERY, AS PT DID NOT HAVE ADEQUATE USE OF THE ARM. THE ENTIRE EPOCA CONSTRUCT (HEAD, ECCENTER AND STEM) WAS REMOVED AND PT WAS REVISED TO COMPETITIVE HARDWARE. THIS IS THE 1ST OF 3 REPORTS SUBMITTED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COCR HEAD 54MM/20.25MM - STERILE | COCR HEAD | HSD | SYNTHES MONUMENT | NA | C000149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | ECCENTER| STEM |