FDA Adverse Event
Injury
Summary report: N
RECAP MAGNUM SHELL
MDR report key: 2103673
·
Received May 20, 2011
Report
- Report Number
- 3002806535-2011-00071
- Event Type
- Injury
- Date Received
- May 20, 2011
- Date of Event
- November 17, 2010
- Report Date
- April 21, 2011
- Manufacturer
- BIOMET UK LTD.
- Product Code
- KWA
- PMA / PMN Number
- K042037
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS REC'D. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS REPORT FILED (B)(4), 2011.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT UNDERWENT PRIMARY HIP PROCEDURE ON (B)(6), 2007. PT UNDERWENT REVISION SURGERY ON (B)(6), 2010. NO OTHER INFORMATION WAS REPORTED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RECAP MAGNUM SHELL | KWA | BIOMET UK LTD. | NA | 1166732 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R |