1818910-2022-08536
Report
- Report Number
- 1818910-2022-08536
- Event Type
- Injury
- Date Received
- May 10, 2022
- Date of Event
- December 1, 2020
- Report Date
- May 10, 2022
- Manufacturer
- DEPUY ORTHOPAEDICS, INC. 1818910
- Product Code
- LPH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR MANUFACTURING RECORD EVALUATION, WAS NOT POSSIBLE AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
REVISION COMPLETED DUE TO DISLOCATION. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT HIP.
REVISION COMPLETED DUE TO DISLOCATION. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1295983 | LPH | ||||||
| 1387163 | LPH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Required Intervention| R | ZIMMER CONTINUUM SIZ #60 CUP WITH 2X 30-MM SCREWS| ZIMMER CONTINUUM SIZ #60 CUP WITH 2X 30-MM SCREWS |
| 1 | 72 YR | Male | Required Intervention| R | ZIMMER CONTINUUM SIZ #60 CUP WITH 2X 30-MM SCREWS| ZIMMER CONTINUUM SIZ #60 CUP WITH 2X 30-MM SCREWS |