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 9700889
- MDR report key
- 9700889
- Report number
- 1818910-2020-04613
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-27
- Date received
- 2020-02-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KARA DITTY-BOVARD
- Address
- 700 ORTHOPAEDIC DR. 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 | MODULAR CATHCART BALL 47MM OD | HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI | DEPUY ORTHOPAEDICS INC US | LZY | 1363-47-000 | 136347000 | D18030240 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-12 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. CONVERTED A UNIPOLAR HIP TO A TOTAL HIP. WE COULD NOT TELL WHAT SIZE THE SPACER WAS. DOI:UNKNOWN; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.