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 2020-01-20 for E-POLY 40MM +3 MAXROM LNR SZ24 N/A EP-108424 manufactured by Zimmer Biomet, Inc..
[187617213]
(b)(4). Concomitant medical product(s: 650-1064 cer option type 1 tpr sleve -6 2914167; 650-1058 cer bioloxd option hd 40mm 2904573; pt-116056 regen/rnglc+ ltd 56mm sz 24 240160; 51-108080 tprlc 133 mp t1 pps so 8x101mm 6006745. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. 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
[187617214]
It was reported that patient underwent right total hip arthroplasty and subsequently was revised three months later due dislocation. The head and liner components were removed and replaced. Attempts were made to obtain additional information; however, none was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-00290 |
| MDR Report Key | 9608257 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-20 |
| Date of Event | 2018-06-27 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2017-02-08 |
| Date Added to Maude | 2020-01-20 |
| 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 40MM +3 MAXROM LNR SZ24 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OIY |
| Date Received | 2020-01-20 |
| Model Number | N/A |
| Catalog Number | EP-108424 |
| Lot Number | 538330 |
| 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 | 2020-01-20 |