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 2018-03-14 for E-POLY 40MM +3 MAXROM LNR SZ24 N/A EP-108424 manufactured by Zimmer Biomet, Inc..
[102433509]
(b)(4). Medical devices: 11-301303, arcos con sz c std 60mm, 163470, s001140, selex/magnum mod hd 40mm std, 626430. Customer has indicated that the product will not be returned to zimmer biomet for investigation. 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 - 01787, 0001825034 - 2018 - 01789. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[102433510]
It was reported that the patient experienced blood loss of 1400 ml during a stage ii revision procedure. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-01788 |
| MDR Report Key | 7339122 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-03-14 |
| Date of Report | 2018-10-09 |
| Date of Event | 2011-08-11 |
| Date Mfgr Received | 2018-10-02 |
| Date Added to Maude | 2018-03-14 |
| 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 | . |
| 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 40MM +3 MAXROM LNR SZ24 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | MAY |
| Date Received | 2018-03-14 |
| Model Number | N/A |
| Catalog Number | EP-108424 |
| Lot Number | 878960 |
| ID Number | N/A |
| Device Expiration Date | 2016-02-28 |
| 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. Hospitalization; 2. Other | 2018-03-14 |