FDA Adverse Event
Injury
Summary report: N
ENDURON 10D 54OD X 26ID
MDR report key: 6871981
·
Received September 18, 2017
Report
- Report Number
- 1818910-2017-24903
- Event Type
- Injury
- Date Received
- September 18, 2017
- Date of Event
- August 22, 2017
- Report Date
- August 22, 2017
- Manufacturer
- DEPUY ORTHOPAEDICS, INC. 1818910
- Product Code
- HRY
- PMA / PMN Number
- K944538
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative · 1
NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
THE PATIENT WAS REVISED TO ADDRESS POLY WEAR AND OSTEOLYSIS. IT WAS STATED THAT THE SURGEON DID HEAD AND POLY EXCHANGE WITH BONE GRAFTING. KEPT STEM 1520-67-000 L-544290001 AND CUP 1226-54-501 L- 839850013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652960 | ENDURON 10D 54OD X 26ID | HIP ACETABULAR INSERT/LINER | HRY | DEPUY ORTHOPAEDICS, INC. 1818910 | 717770018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |