FDA Adverse Event
Injury
Summary report: N
SHP ARCOM ACETABULAR CUP
MDR report key: 1251941
·
Received December 3, 2008
Report
- Report Number
- 3002806535-2008-00022
- Event Type
- Injury
- Date Received
- December 3, 2008
- Date of Event
- October 9, 2008
- Report Date
- November 7, 2008
- Manufacturer
- BIOMET UK LTD.
- Product Code
- JDI
- PMA / PMN Number
- K960984
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFO IS AVAILABLE. EVALUATION IN PROCESS, BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT UNDERWENT TOTAL HIP ARTHROPLASTY IN 2000. CUP SHELL, MODULAR HEAD AND HIP STEM WERE REVISED IN 2008, DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHP ARCOM ACETABULAR CUP | JDI | BIOMET UK LTD. | NA | 349224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |