D
Patient 1
PT HAD STAPH INFECTION 2-3 MONTHS POST-OP WHICH DID NOT RESPOND TO CONSERVATIVE TREATMENT. THEREFORE, THE PT WAS REVISED AND A CEMENT SPACER IMPLANTED.
MAUDE MDR 1692248
- MDR report key
- 1692248
- Report number
- 1818910-2010-02862
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-04-14
- Date received
- 2010-05-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- KATHERINE SEPPA, MGR
- Address
- 700 ORTHOPAEDIC DR. WARSAW IN 46581 US
- Phone
- 574-574-5743
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CEM RESTRICTOR LG | 87JDS | DEPUY ORTHOPAEDICS, INC. | JDK | NA | 546112000 | DX9KT1000 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-05-14 | 0 | 1. R |
Event Narratives#
N
Patient 1
NO PRODUCT WAS RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE REPORTED PRODUCT LOT CODE. 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 ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.