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 38MM +5HW LNR NI EP-195234 manufactured by Zimmer Biomet, Inc..
[166370465]
(b)(4). Concomitant medical products: pt-106058- regen/rnglc+ multi- 587490, 11-173663- m2a 38mm mod hd- 005910, 103533- ti low profile screw- 366080, 103538- ti low profile screw- 170890, 103535- ti low profile screw- 199290, 31-323230-rnglc+ acet drl bit- 466490, 31-323240-rnglc+ acet drl bit- 572480. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 -05121, 0001825034 -2019 -05124. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product location unknown.
Patient Sequence No: 1, Text Type: N, H10
[166370466]
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 | 0001825034-2019-05122 |
| MDR Report Key | 9311954 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-11-12 |
| Date of Report | 2019-11-12 |
| Date of Event | 2013-07-01 |
| Date Mfgr Received | 2019-10-22 |
| Device Manufacturer Date | 2008-02-01 |
| 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 38MM +5HW LNR |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OIY |
| Date Received | 2019-11-12 |
| Model Number | NI |
| Catalog Number | EP-195234 |
| Lot Number | 933920 |
| Device Expiration Date | 2011-02-28 |
| 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 |