MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-04-26 for PERSONA VIVACITE ARTICULAR SURFACE 42522400710 manufactured by Zimmer, Inc. - Building 5.
[43624145]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[43624146]
It is reported that the patient was revised due to instability in the right knee.
Patient Sequence No: 1, Text Type: D, B5
[74521349]
Reported event could not be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Review of complaint history determined that no further action is required as no trends were identified. The associated package insert warns that this type of event can occur. Under? Adverse effects? It lists? Dislocation and/or joint instability? As an adverse effect of this procedure. Root cause could not 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
[75839992]
This follow-up report is being submitted to relay additional and corrected information. Reported event was confirmed through a review of patient's medical records, which indicated the patient was revised due to instability. Dhr was reviewed and no discrepancies were found. Review of complaint history determined that no further action is required as no trends were identified. The associated package insert warns that this type of event can occur. Under? Adverse effects? It lists? Dislocation and/or joint instability? As an adverse effect of this procedure. Root cause could not 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 | 0001822565-2016-01314 |
| MDR Report Key | 5607683 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-04-26 |
| Date of Report | 2017-05-04 |
| Date of Event | 2015-04-27 |
| Date Mfgr Received | 2017-04-24 |
| Device Manufacturer Date | 2012-10-15 |
| Date Added to Maude | 2016-04-26 |
| 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 | MR. KEVIN ESCAPULE |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal | 46580 |
| Manufacturer Phone | 8006136131 |
| Manufacturer G1 | ZIMMER, INC. - BUILDING 5 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERSONA VIVACITE ARTICULAR SURFACE |
| Generic Name | OIY |
| Product Code | IOY |
| Date Received | 2016-04-26 |
| Catalog Number | 42522400710 |
| Lot Number | 62175985 |
| Device Expiration Date | 2017-09-30 |
| 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. - BUILDING 5 |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-26 |