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 2016-09-19 for VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINER 00885201236 manufactured by Zimmer, Inc..
[55029628]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[55029629]
It is reported that the patient's hip arthroplasty was revised due to infection.
Patient Sequence No: 1, Text Type: D, B5
[60319444]
Patient Sequence No: 1, Text Type: N, H10
[134083322]
This follow-up report is being submitted to relay corrected and additional information. Concomitant medical products: item 00784301308, revision femoral stem, lot # 62509389; item 00875705601, shell with cluster holes, lot # unknown. Unknown cocr cables with ti crimp cocr cables unknown biolox ceramic head. Reported event was confirmed by review of the provided medical records. Device history record was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required. Review of sterilization certificate confirmed the device was sterilized in accordance with procedure and regulations. Root cause was unable to be determined as the necessary information. There are warnings in the package insert that this type of event can occur and associated risks are addressed in risk documentation. 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
[134083323]
Additional information received in patient's medical records indicate the head and liner were revised and irrigation and debridement. Durinig the procedure, serosanguinous fluid was found down to fascia when irrigated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2016-03285 |
| MDR Report Key | 5959821 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-09-19 |
| Date of Report | 2017-12-06 |
| Date of Event | 2014-10-15 |
| Date Mfgr Received | 2017-12-05 |
| Device Manufacturer Date | 2014-07-08 |
| Date Added to Maude | 2016-09-19 |
| 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 VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINER |
| Generic Name | HIP PROSTHESIS |
| Product Code | OQI |
| Date Received | 2016-09-19 |
| Catalog Number | 00885201236 |
| Lot Number | 62720387 |
| Device Expiration Date | 2019-05-31 |
| 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 | 2016-09-19 |