FDA Adverse Event
Injury
Summary report: N
DURAMER(R) INTERSEAL(R) LINER
MDR report key: 2993442
·
Received March 7, 2013
Report
- Report Number
- 1043534-2013-00495
- Event Type
- Injury
- Date Received
- March 7, 2013
- Date of Event
- February 13, 2004
- Report Date
- January 29, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LPH
- PMA / PMN Number
- K931333
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN.THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.(B)(4).
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00496.
Description of Event or Problem · 1
ALLEGEDLY PATIENT HAD EXCESSIVE WEAR OF THE ACETABULAR COMPONENT WITH INCREASING PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97849 | DURAMER(R) INTERSEAL(R) LINER | HIP COMPONENT, CODE:LPH | LPH | WRIGHT MEDICAL TECHNOLOGY, INC. | 047A062779 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |