FDA Adverse Event
Injury
Summary report: N
TOTAL HIP BALL 32MM +11
MDR report key: 1812436
·
Received August 16, 2010
Report
- Report Number
- 1818910-2010-05501
- Event Type
- Injury
- Date Received
- August 16, 2010
- Date of Event
- July 19, 2010
- Report Date
- July 19, 2010
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- JDI
- PMA / PMN Number
- K853655
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE PROVIDED INFO. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS DISLOCATION. IT WAS REPORTED THAT THE PT FELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTAL HIP BALL 32MM +11 | 87JDI | JDI | DEPUY INTERNATIONAL, LTD. | NA | 2939568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |