MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-04-19 for IMPACTOR FOR ACETABULAR CUP N/A 00151603044 manufactured by Zimmer Biomet, Inc..
[106033642]
(b)(4). (b)(6). Complaint sample was evaluated and the reported event was confirmed. Visual inspection of the returned product showed small hairline cracks can be observed on the top of the cap near the threaded screw hole. Signs of wear were observed on the impactor insert. Metal particulates are embedded in the surface of the cap. Dimensional readings are conforming to print specifications. Device history record was reviewed and no discrepancies 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
[106033643]
It was reported that there is metal residue embedded in the acetabular shell impactor and the customer is requesting a replacement. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
[130083177]
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
[130083178]
No further information
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-02285 |
| MDR Report Key | 7444449 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-04-19 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-02-21 |
| Date Mfgr Received | 2018-12-12 |
| Device Manufacturer Date | 2015-02-19 |
| Date Added to Maude | 2018-04-19 |
| 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 | IMPACTOR FOR ACETABULAR CUP |
| Product Code | NLF |
| Date Received | 2018-04-19 |
| Returned To Mfg | 2018-04-05 |
| Model Number | N/A |
| Catalog Number | 00151603044 |
| Lot Number | 62989802 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-04-19 |