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 2018-03-19 for BIOMET E-POLY LINER N/A EP-108323 manufactured by Zimmer Biomet, Inc..
[102839040]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested, but not returned by the hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # 11-363660, femoral head, lot # 641190, item # 12-104158, shell, lot # 972760, item # hips-unknown-stems-unk, lot # unk. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[102839041]
It was reported that the patient underwent a revision surgery approximately 6 years post implantation due to poly liner wear. Attempts have been made, and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[114888025]
This follow up report is being submitted to report additional information. Reported event was confirmed through photographs received. Photographs of the explanted head and liner were provided. The liner is completely worn and fractured into multiple pieces and scratches were noted on explanted cocr head outer surface. However, no further evaluation can be performed based using the photographs provided and dimensional evaluations could not be performed since the product is not returned. Device history record (dhr) was reviewed and no discrepancies were found. Review of complaint history determined that no further action is required. Root cause was unable to be determined. 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
| Report Number | 0001825034-2018-01842 |
| MDR Report Key | 7351256 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-19 |
| Date of Report | 2018-03-29 |
| Date of Event | 2017-12-22 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2018-03-19 |
| 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 |
| 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 | BIOMET E-POLY LINER |
| Generic Name | HIP PROSTHESIS |
| Product Code | MAY |
| Date Received | 2018-03-19 |
| Model Number | N/A |
| Catalog Number | EP-108323 |
| Lot Number | 155640 |
| ID Number | N/A |
| Device Expiration Date | 2015-12-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-03-19 |