N
Patient 1
(B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
MAUDE MDR 9898157
- MDR report key
- 9898157
- Report number
- 0001822565-2020-01138
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-11-01
- Date received
- 2020-03-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- 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 | SYSTEM RASP LONG POST SIZE 4 | PROSTHESIS, HIP | ZIMMER BIOMET, INC. | LXH | N/A | 00771200460 | 62677214 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-30 | 0 | 1. H; 2. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED DURING A HIP PROCEDURE, THE M/L TAPER RASP FRACTURED. THE FRAGMENT WAS FOUND APPROXIMATELY 4 MONTHS POST OPERATION IN A CONTROL X-RAY PICTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.