N
Patient 1
(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
MAUDE MDR 9904040
- MDR report key
- 9904040
- Report number
- 1818910-2020-09741
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-12
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Contact
- KARA DITTY-BOVARD
- Address
- 700 ORTHOPAEDIC DRIVE WARSAW IN 46581 US
- Phone
- 610-610-6107
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN HIP ACETABULAR LINERS | HIP ACETABULAR LINERS | DEPUY ORTHOPAEDICS INC US | KWA | UNK HIP ACETABULAR LINER | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |
Event Narratives#
D
Patient 1
REVISION FOR: OSTEOLYSIS LOOSENING WEAR INSTABILITY. SIGNIFICANT WEAR OF ACETABULAR POLYETHYLENE LINER, SIGNIFICANT OSTEOLYSIS IN ACETABULAR PELVIC BONE AND AROUND PROXIMAL AREA OF FEMORAL COMPONENT. FEMORAL COMPONENT WELL FIXED AND REMAINED INSITU. ACETABULAR COMPONENT REVISION WITH FEMORAL HEAD REPLACED (ACETABULAR COMPONENT REVISED BONE GRAFT IMPLANTED TO FILL DEFECTS).