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 2016-06-20 for VIVACIT-E POLYETHYLENE NEUTRAL LINER 00885101240 manufactured by Zimmer, Inc..
[47735657]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[47735658]
It is reported the patient is experiencing a 1 1/2 inch leg length discrepancy and the need to wear special shoes with a lift.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2016-02100 |
| MDR Report Key | 5735659 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-06-20 |
| Date of Report | 2016-05-25 |
| Date Mfgr Received | 2016-05-25 |
| Device Manufacturer Date | 2015-10-28 |
| Date Added to Maude | 2016-06-20 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 POLYETHYLENE NEUTRAL LINER |
| Generic Name | HIP PROSTHESIS |
| Product Code | OQI |
| Date Received | 2016-06-20 |
| Catalog Number | 00885101240 |
| Lot Number | 63189619 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other | 2016-06-20 |