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 2019-11-14 for E-POLY 40MM +3 HIWALL LNR SZ25 NI EP-108525 manufactured by Zimmer Biomet, Inc..
[168057633]
(b)(4). Concomitant medical products: pt-106062-regen/rnglc+ multi-253460, s991140-selex/magnum mod-688000, 103534-ti low profile screw-155530, 103533-ti low profile screw-155480. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05126, 0001825034 - 2019 - 05129. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product location unknown.
Patient Sequence No: 1, Text Type: N, H10
[168057634]
It was reported the patient underwent an initial hip arthroplasty. Subsequently, the patient underwent an acetabular revision due to unknown reasons a little over two years later. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-05127 |
| MDR Report Key | 9321261 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-11-14 |
| Date of Report | 2019-11-12 |
| Date of Event | 2015-02-20 |
| Date Mfgr Received | 2019-10-22 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2019-11-14 |
| 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 | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-POLY 40MM +3 HIWALL LNR SZ25 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OIY |
| Date Received | 2019-11-14 |
| Model Number | NI |
| Catalog Number | EP-108525 |
| Lot Number | 619190 |
| Device Expiration Date | 2018-02-28 |
| 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 | 2019-11-14 |