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 2016-05-17 for VIVACIT-E CROSSLINKED POLYETHYLENE ELEVATED RIM LINER N/A 00885201032 manufactured by Zimmer, Inc..
[45302226]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[45302227]
It is reported that the liner couldn't be assembled into the cup.
Patient Sequence No: 1, Text Type: D, B5
[47235253]
This report is being amended to reflect changes in sections. Received, not yet evaluated.
Patient Sequence No: 1, Text Type: N, H10
[49424688]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[59591630]
An elevated rim liner was returned for evaluation. As returned, the locking features exhibit damage. The device history record (dhr) review shows that the surface profile of anti-rotation features, od spherical radius, locking features, and taper are 100% inspected at the time of manufacture. Inspection documentation shows all devices that were accepted, completed, and sent to inventory met specifications. The shell was not returned because it remains implanted, therefore, no physical evaluation could be conducted. The dhrs were reviewed and indicate the devices were manufactured to specifications, with no anomalies or deviations that would have affected the surgical outcome or contributed to the reported event. These devices are used for treatment. Complaint history searches found there are no additional complaints for the product part/lot combinations involved. Due to the shell remaining implanted and unable to evaluate, a specific cause for the reported condition could not be determined with certainty.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001822565-2016-01596 |
| MDR Report Key | 5659426 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-05-17 |
| Date of Report | 2016-04-22 |
| Date of Event | 2016-04-14 |
| Date Mfgr Received | 2016-10-18 |
| Device Manufacturer Date | 2015-01-08 |
| Date Added to Maude | 2016-05-17 |
| 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. CARRIE SCHNEIDER |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| 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 CROSSLINKED POLYETHYLENE ELEVATED RIM LINER |
| Generic Name | OQI |
| Product Code | OQI |
| Date Received | 2016-05-17 |
| Returned To Mfg | 2016-05-17 |
| Model Number | N/A |
| Catalog Number | 00885201032 |
| Lot Number | 62913187 |
| ID Number | N/A |
| Device Expiration Date | 2019-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-05-17 |