MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-03-23 for VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE NEUTRAL LINER N/A 00885101132 manufactured by Zimmer Biomet, Inc..
[103293154]
(b)(4). No product was explanted; therefore, no product will be returned. Investigation is in process. Once the investigation has been completed a follow up mdr will be submitted. Concomitant medical products: medical device: item#00875705401, acetabular cup lot#63069866; medical device: item#00877503202, femoral head lot# 2778801; medical device: item#00771101020, femoral stem lot#63007590. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-01553; 0001822565-2018-01557.
Patient Sequence No: 1, Text Type: N, H10
[103293155]
It was reported that patient is experiencing mild right hip pain in front thigh and outer groin approximately two years post- right total hip arthroplasty. Patient is continuing to follow up with physician and currently takes nsaids as necessary. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[134239657]
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was not confirmed. X-ray review noted varus alignment of the femoral stem may contribute to thigh pain, but cannot be confirmed. 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
[134239658]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-01555 |
| MDR Report Key | 7365262 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-23 |
| Date of Report | 2018-04-06 |
| Date of Event | 2017-12-01 |
| Date Mfgr Received | 2018-04-06 |
| Device Manufacturer Date | 2015-06-26 |
| Date Added to Maude | 2018-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE NEUTRAL LINER |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OQI |
| Date Received | 2018-03-23 |
| Model Number | N/A |
| Catalog Number | 00885101132 |
| Lot Number | 63090268 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2018-03-23 |