FDA Adverse Event
Injury
Summary report: N
SUMMIT POR TAPER SZ6 STD OFF
MDR report key: 1822874
·
Received August 25, 2010
Report
- Report Number
- 1818910-2010-05735
- Event Type
- Injury
- Date Received
- August 25, 2010
- Date of Event
- July 12, 2010
- Report Date
- July 29, 2010
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- MRA
- PMA / PMN Number
- P040023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCTS WERE RETURNED. REVIEW OF THE STERILIZATION CERTIFICATES DID NOT REVEAL ANY ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT LOT CODES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED INFECTION. 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 ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUMMIT POR TAPER SZ6 STD OFF | 87MRA | MRA | DEPUY ORTHOPAEDICS, INC. | NA | ER9B41 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |