FDA Adverse Event
Injury
Summary report: N
TI HUMERAL STEM PRESS-FIT, SIZE 14/135MM-STERILE
MDR report key: 2151595
·
Received June 29, 2011
Report
- Report Number
- 1719045-2011-00327
- 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 ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER. ADDITIONAL INFO 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 WAS REMOVED AND PT WAS REVISED TO COMPETITIVE HARDWARE. THIS IS THE 3RD OF 3 REPORTS SUBMITTED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI HUMERAL STEM PRESS-FIT, SIZE 14/135MM-STERILE | HUMERAL STEM | HSD | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | HEAD| ECCENTER |