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 2018-04-10 for E-POLY 40MM +3 HIWALL LNR SZ24 N/A EP-108524 manufactured by Zimmer Biomet, Inc..
[105143841]
(b)(4). Multiple mdr's were reported for this event. Please also see associated events: 0001825034 - 2018 - 02364, 0001825034 - 2018 - 02366, 0001825034 - 2018 - 02367. Concomitant medical products: pt-106056 regen/rnglc+ multi 56mm sz 24 lot 752890, ep-108524 e-poly 40mm +3 hiwall lnr sz24 lot 168940, 16-116054 rnglc+ ltd hole shell sz54 lot 720230. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[105143842]
It was reported the acetabular liner would not lock into the acetabular cup, resulting in a delay of 1-2 hours. Attempts have been made and no further information has been made available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-02365 |
| MDR Report Key | 7416626 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-04-10 |
| Date of Report | 2018-09-18 |
| Date of Event | 2018-03-16 |
| Date Mfgr Received | 2018-08-27 |
| Device Manufacturer Date | 2017-07-18 |
| Date Added to Maude | 2018-04-10 |
| 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 HIWALL LNR SZ24 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | MAY |
| Date Received | 2018-04-10 |
| Returned To Mfg | 2018-03-28 |
| Model Number | N/A |
| Catalog Number | EP-108524 |
| Lot Number | 925850 |
| ID Number | (01) EP-108524 |
| Operator | PHYSICIAN |
| 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. Required No Informationntervention | 2018-04-10 |