MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2018-10-24 for E-POLY HIWALL LINER N/A EP-108524 manufactured by Zimmer Biomet, Inc..
[124829530]
(b)(4). Concomitant medical devices: tri-spike shell w/apex hl 54mm, # item 101005,? Lot: 644750;?? Integral/x por red prox 13mm, # item x12-171313, lot: 205690;? Selex/magnum mod hd 40mm +3, # item s331140, lot: 376410. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-09839. It is unknown if product will be returning to 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
[124829531]
It was reported that patient underwent a revision procedure approximately five years post initial hip surgery due to pain, feeling dizzy, and dislocation. The patient alleges metallosis, severe nerve damage to the muscles and tissues. Attempts to obtain additional information have been made; however, no more is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-09837 |
| MDR Report Key | 7999724 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-06-05 |
| Date Mfgr Received | 2018-09-24 |
| Device Manufacturer Date | 2013-08-29 |
| Date Added to Maude | 2018-10-24 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-POLY HIWALL LINER |
| Generic Name | PROSTHESIS HIP |
| Product Code | MAY |
| Date Received | 2018-10-24 |
| Model Number | N/A |
| Catalog Number | EP-108524 |
| Lot Number | 376410 |
| Device Expiration Date | 2018-08-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-10-24 |