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 2019-11-12 for E-POLY 40MM +3 HIWALL LNR NI EP-108525 manufactured by Zimmer Biomet, Inc..
[166197258]
(b)(4). Concomitant medical products: 010001032- cocr fem hd- 3147102, 21-109268- ha par-5 acet shl- 779130, x12-171313- integral/x por red- 299620, 31-109200- par-5 flange prov sz short lt- 307940, 109206- par-5 flange sz short neutral- 299720, 31-323230-rnglc+ acet drl bit- 784290, 103532- ti low profile screw- 678040, 31-323220-rnglc+ acet drl bit- 031580, 103531- ti low profile screw- 558060, 103531- ti low profile screw- 633300. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05113, 0001825034 - 2019 - 05114, 0001825034 - 2019 - 05115. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[166197259]
It was reported patient has been indicated for revision due to unknown reason; however, no revision has been reported to date. 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 | 0001825034-2019-05112 |
| MDR Report Key | 9311963 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-11-12 |
| Date of Report | 2019-11-12 |
| Date Mfgr Received | 2019-10-22 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2019-11-12 |
| 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 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OIY |
| Date Received | 2019-11-12 |
| Model Number | NI |
| Catalog Number | EP-108525 |
| Lot Number | 181790 |
| Device Expiration Date | 2019-05-30 |
| 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. Other | 2019-11-12 |