MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2020-03-20 for E-POLY 40MM +3 HIWALL LNR SZ24 N/A EP-108524 manufactured by Zimmer Biomet, Inc..
[184461320]
(b)(4). Concomitant medical products: 00801804002 62358028 12/14 cocr femoral head 40mm +0, 00771300900 62309332 m/l taper kinectiv stem size 9, 00784803201 62198159 kinectiv modular neck g2, 103531 939930 ti low profile screw 6. 5x20mm, 106054 884870 ran/bur rnglc shl 54mm sz 24, 103531 405190 ti low profile screw 6. 5x20mm. 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. Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00025 head, 0001822565 - 2020 - 00152 neck, 0001822565 - 2020 - 00961 stem, 0001825034 - 2020 - 01204 shell.
Patient Sequence No: 1, Text Type: N, H10
[184461321]
It was reported by patients? Legal counsel that the patient underwent a right hip revision procedure approximately 5 years post-implantation due to metallosis, tissue damage, periprosthetic fracture and infection, polyethylene failure. All devices removed due to infection. Spacers implanted. Attempts were made to obtain additional information; however, none was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-01203 |
| MDR Report Key | 9859736 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-19 |
| Date of Event | 2018-03-11 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2013-10-28 |
| Date Added to Maude | 2020-03-20 |
| 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 HIWALL LNR SZ24 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | MAY |
| Date Received | 2020-03-20 |
| Model Number | N/A |
| Catalog Number | EP-108524 |
| Lot Number | 921590 |
| Device Expiration Date | 2018-10-31 |
| 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 | 2020-03-20 |