FDA Adverse Event
Injury
Summary report: N
ALTRX +4 10D 32IDX50OD
MDR report key: 6176695
·
Received December 15, 2016
Report
- Report Number
- 1818910-2016-33527
- Event Type
- Injury
- Date Received
- December 15, 2016
- Date of Event
- December 12, 2016
- Report Date
- December 12, 2016
- Manufacturer
- 1818910 DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- PMA / PMN Number
- K062148
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
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. (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
PATIENT WAS REVISED DUE TO DISASSOCIATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 827181 | ALTRX +4 10D 32IDX50OD | HIP ACETABULAR INSERT/LINER | LPH | 1818910 DEPUY ORTHOPAEDICS, INC. | 495024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |