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 2018-06-21 for E-POLY 36MM +3 HIWALL LNR SZ23 N/A EP-108323 manufactured by Zimmer Biomet, Inc..
[111853020]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Event date-onset of pain occurred on an unknown day in 2001 concomitant medical products: item # unk, hip-unknown-stems-unk, lot # unk, item # 650-1057, femoral head, lot # 316860, item # 650-1062, taper adapter, lot # 525920, item # 11-105150, cup, lot # 138250. Multiple reports have been submitted for this event. Please see associated reports: 0001825034-2018-04177, 0001825034-2018-04178, 0001825034-2018-04179, 0001825034-2014-00478, 0001825034-2018-04180.
Patient Sequence No: 1, Text Type: N, H10
[111853022]
It was reported that a patient is currently experiencing ongoing pain approximately 6 years post implantation. Attempts have been made, and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-04180 |
| MDR Report Key | 7624686 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-06-21 |
| Date of Report | 2018-09-25 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2011-11-27 |
| Date Added to Maude | 2018-06-21 |
| 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 36MM +3 HIWALL LNR SZ23 |
| Generic Name | HIP PROSTHESIS |
| Product Code | MAY |
| Date Received | 2018-06-21 |
| Model Number | N/A |
| Catalog Number | EP-108323 |
| Lot Number | 211480 |
| ID Number | N/A |
| Device Expiration Date | 2016-11-30 |
| Operator | PHYSICIAN |
| 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. Other | 2018-06-21 |