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 2016-09-09 for ZIMMER VITAMIN-E ELEVATED LINER 00885201136 manufactured by Zimmer, Inc..
[54350018]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[54350019]
It is reported the patient was revised due to infection following a hip arthroplasty.
Patient Sequence No: 1, Text Type: D, B5
[110401284]
This follow-up report is being submitted to relay additional information. Concomitant medical product: continuum trabecular metal shell with cluster holes, catalog#: 00875705401, lot#: 62762955. Bone screw self-tapping, catalog#: 00625006520, lot#: 62757373. Bone screw self-tapping, catalog#: 00625006515, lot#: 77002942. Biolox delta option ceramic head, catalog#: 650-1057, lot#: 039210. Biolox option taper adapter, catalog#: 650-1065, lot#: 339950. Teperloc porous lateral femoral, catalog#: 11-103203, lot#: 585060. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action(s) is/are required. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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
[110401285]
It is reported the patient underwent an exploration of the left total hip replacement with revision of the femoral and acetabular components due to pain after a prior revision. Upon entering the hip, the femoral head was removed. The stem remained, as it was well fixed. It was noted that there was no evidence of loosening was noted. Synovial fluid was slightly cloudy, yellowish in appearance and sent for gram stain. There was no evidence of infection noted. The shell remained implanted as well, however the screws were replaced. The liner was replaced with a new vitamin e poly liner. A new ceramic head with a -3. 0 adapter was implanted as well. After the hip was reduced, it had excellent range of motion and stability. No intraoperative complications were noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2016-03209 |
| MDR Report Key | 5940213 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-09-09 |
| Date of Report | 2017-08-04 |
| Date of Event | 2015-09-08 |
| Date Mfgr Received | 2017-07-31 |
| Device Manufacturer Date | 2014-07-08 |
| Date Added to Maude | 2016-09-09 |
| 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 465820708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820708 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER VITAMIN-E ELEVATED LINER |
| Generic Name | HIP PROSTHESIS |
| Product Code | OQI |
| Date Received | 2016-09-09 |
| Catalog Number | 00885201136 |
| Lot Number | 62727141 |
| Device Expiration Date | 2019-06-30 |
| 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. |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-09-09 |