N
Patient 1
(B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
MAUDE MDR 7841784
- MDR report key
- 7841784
- Report number
- 3002806535-2018-01047
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-10-02
- Date received
- 2018-09-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. CHRISTINA ARNT
- Address
- 56 E. BELL DR. WARSAW IN 46582 US
- Phone
- 574-574-5745
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 32MM MOD HEAD COCR +12MM NECK | HIP PROSTHESIS | BIOMET UK LTD. | JDB | N/A | 163673 | 0000587055 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-09-04 | 0 | 1. H; 2. R |
Event Narratives#
D
Patient 1
IT HAS BEEN REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY AND SUBSEQUENTLY THE PATIENT EXPERIENCED AN INFECTION AND A WOUND WASHOUT PROCEDURE WAS PERFORMED.