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 2018-10-24 for E-POLY 36MM +3 HIWALL LINER SZ23 N/A EP-108323 manufactured by Zimmer Biomet, Inc..
[124888676]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted. 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: 0001825034 - 2018 - 09876, 0001825034 - 2018 - 09877, 0001825034 - 2018 - 09878.
Patient Sequence No: 1, Text Type: N, H10
[124888677]
It was reported patient developed infection, causing incisional drainage 2 weeks post-operative initial hip procedure. Patient was treated with oral antibiotics. The drainage resolved and incision was well healed by 7 week follow up. No further treatment required. 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 | 0001825034-2018-09875 |
| MDR Report Key | 8001747 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-10-24 |
| Date of Report | 2019-02-22 |
| Date of Event | 2017-04-05 |
| Date Mfgr Received | 2019-02-21 |
| Device Manufacturer Date | 2016-11-28 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-POLY 36MM +3 HIWALL LINER SZ23 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | MAY |
| Date Received | 2018-10-24 |
| Model Number | N/A |
| Catalog Number | EP-108323 |
| Lot Number | 272260 |
| 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. Required No Informationntervention | 2018-10-24 |