MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-10-11 for VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE LINER 00885101236 manufactured by Zimmer, Inc..
[56926876]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[56926877]
It is reported that the patient's hip arthroplasty was revised due to infection.
Patient Sequence No: 1, Text Type: D, B5
[75025352]
This follow-up report is being submitted to relay additional information. Device was not returned so no product evaluation could be conducted. This device was used for treatment. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. 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
| Report Number | 0001822565-2016-03641 |
| MDR Report Key | 6016421 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-10-11 |
| Date of Report | 2017-05-08 |
| Date of Event | 2016-09-01 |
| Date Mfgr Received | 2017-05-08 |
| Device Manufacturer Date | 2015-10-12 |
| Date Added to Maude | 2016-10-11 |
| 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, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| 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 LINER |
| Generic Name | HIP PROSTHESIS |
| Product Code | OQI |
| Date Received | 2016-10-11 |
| Catalog Number | 00885101236 |
| Lot Number | 63180389 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-10-11 |