N
Patient 1
(B)(4). FOREIGN COUNTRY: (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 7850277
- MDR report key
- 7850277
- Report number
- 0001822565-2018-04852
- Event key
- 0
- Event type
- 3
- Date received
- 2018-09-06
- Adverse event
- 0
- 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 | ZIMMER MAXERA CUP IMPACTOR | INSTRUMENTATION, HIP | ZIMMER BIOMET, INC. | NLF | N/A | 00151603040 | 63148868 | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-09-06 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT AN IMPACTOR WAS RETURNED CRACKED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
N
Patient 1
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: IT WAS IDENTIFIED AN INTERNAL SOFTWARE ERROR PRODUCED AND SUBMITTED AN INVALID DEVICE PRODUCT CODE IN THE PREVIOUS SUBMISSIONS RELATED TO THIS REPORTING. THE DEVICE PRODUCT CODE HAS BEEN UPDATED WITH NO FURTHER CHANGES. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
D
Patient 1
NO FURTHER INFORMATION AVAILABLE
N
Patient 1
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION IDENTIFIED CRACKS AND METAL DEBRIS EMBEDDED ON THE SURFACE. WEAR AND TEAR CONSISTENT WITH A POTENTIAL FIELD AGE OF APPROXIMATELY 2 YEARS AND 11 MONTHS WAS NOTED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
D
Patient 1
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.