MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-09-06 for ZIMMER MAXERA CUP IMPACTOR N/A 00151603040 manufactured by Zimmer Biomet, Inc..
[119341208]
(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.
Patient Sequence No: 1, Text Type: N, H10
[119341229]
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.
Patient Sequence No: 1, Text Type: D, B5
[130084284]
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.
Patient Sequence No: 1, Text Type: N, H10
[130084285]
No further information available
Patient Sequence No: 1, Text Type: D, B5
[132789243]
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.
Patient Sequence No: 1, Text Type: N, H10
[132789244]
No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-04852 |
| MDR Report Key | 7850277 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-06 |
| Date of Report | 2019-01-04 |
| Date Mfgr Received | 2018-12-31 |
| Device Manufacturer Date | 2015-09-08 |
| Date Added to Maude | 2018-09-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER MAXERA CUP IMPACTOR |
| Generic Name | INSTRUMENTATION, HIP |
| Product Code | NLF |
| Date Received | 2018-09-06 |
| Model Number | N/A |
| Catalog Number | 00151603040 |
| Lot Number | 63148868 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-06 |