MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-30 for UNKNOWN LINER N/A manufactured by Zimmer Biomet, Inc..
[186669603]
(b)(4). Concomitant medical products: catalog #00902602635 zimmer head, lot #66054900, catalog #: unknown, unknown acetabular shell, lot # unknown, catalog #: unknown, unknown zimmer heritage stem, lot # unknown. Reported event was confirmed with the maude report received. Eccentric minimal wear of liner was noted. Device history record review was unable to be performed as the lot number of the device involved in the event is unknown. A definitive root cause cannot be determined with the information 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 00159, 0001822565 - 2019 - 00160.
Patient Sequence No: 1, Text Type: N, H10
[186669604]
It was reported the patient underwent a total hip arthroplasty. Subsequently, patient underwent a revision procedure approximately 20 years post-implantation due to chronic toxic encephalopathy; patient experienced elevated cobalt blood levels, device corrosion and formation of a pseudotumor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-01051 |
| MDR Report Key | 9898280 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2018-12-13 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-30 |
| 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 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN LINER |
| Generic Name | PROSTHESIS, HIP |
| Product Code | KWA |
| Date Received | 2020-03-30 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-30 |