MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-26 for E-POLY 36MM +3 HIWALL LNR SZ23 N/A EP-108323 manufactured by Zimmer Biomet, Inc..
[121845640]
(b)(4). Concomitant medical products: item# unknown, unknown head, lot# unknown; item# unknown, unknown cup, lot# unknown. Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[121845641]
It was reported that patient underwent revision of total hip arthroplasty approximately 6 months after initial implantation due to dislocation, fractured liner, and pain. Attempts have been made to obtain additional information; however, none is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-09077 |
| MDR Report Key | 7911779 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-26 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-09-04 |
| Date Mfgr Received | 2018-10-17 |
| Device Manufacturer Date | 2016-11-28 |
| Date Added to Maude | 2018-09-26 |
| 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 | E-POLY 36MM +3 HIWALL LNR SZ23 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | MAY |
| Date Received | 2018-09-26 |
| Returned To Mfg | 2018-09-12 |
| Model Number | N/A |
| Catalog Number | EP-108323 |
| Lot Number | 272260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-09-26 |