FDA Adverse Event
Injury
Summary report: N
UNK DEPUY INSERT
MDR report key: 1772261
·
Received July 22, 2010
Report
- Report Number
- 1818910-2010-05072
- Event Type
- Injury
- Date Received
- July 22, 2010
- Date of Event
- June 30, 2010
- Report Date
- June 30, 2010
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- HSH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED. THE PRODUCT CODE AND LOT CODE REQUIRED TO RETRIEVE THE DEVICE HISTORY RECORDS FOR REVIEW AND SEARCH THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED INFECTION BASED ON INSUFFICIENT PRODUCT INFO. BASED ON THE PERFORMED INVESTIGATION, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PT REVISED FOR INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK DEPUY INSERT | TOTAL KNEE REPLACEMENT | HSH | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |