N
Patient 1
(B)(4). INITIAL REPORTER OCCUPATION: LAWYER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
MAUDE MDR 9897914
- MDR report key
- 9897914
- Report number
- 1818910-2020-09577
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-08-17
- Date received
- 2020-03-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- 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 | PINNACLE MTL INS NEUT40IDX58OD | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS | DEPUY ORTHOPAEDICS INC US | KWA | 121887458 | 2843789 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-30 | 0 | 1. R |
Event Narratives#
D
Patient 1
AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS PAIN AND METALLOSIS. REVISION NOTES REPORTED THAT THERE WAS NOTED TO BE NO PUS AND ONLY A SMALL AMOUNT OF FLUID. THERE WAS NO METALLOSIS CONSISTING OF GRAYISH OR BLACK STAINING. THERE WAS, HOWEVER, A LARGE AMOUNT OF DARK RED PSEUDOTUMOR TISSUE, THERE WAS MINIMAL AMOUNT OF OSTEOLYSIS AROUND THE CALCAR. THERE WAS LOW-GRADE TENDINOSIS. THERE WAS A SMALL AMOUNT OF BURNISHING SEEN DURING THE REMOVAL OF THE HEAD. DOI: (B)(6) 2009, DOR: (B)(6) 2018, (RIGHT HIP).