MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2018-08-08 for E-POLY 40MM +3 MAXROM LNR SZ25 N/A EP-108425 manufactured by Zimmer Biomet, Inc..
[116397647]
(b)(4). Multiple mdr's were filed for this event. Please see associated report(s): 0001825034-2018-06718. Reported event was confirmed due to review of provided medical records and/or patient x-rays. Dhr was reviewed and no related manufacturing deviations or anomalies were identified. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[116397648]
It was reported the patient had an irrigation and debridement due to mrsa and pseudomonas infection. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-06719 |
| MDR Report Key | 7762000 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2018-08-08 |
| Date of Report | 2018-09-18 |
| Date of Event | 2018-02-12 |
| Date Mfgr Received | 2018-08-22 |
| Device Manufacturer Date | 2010-12-03 |
| Date Added to Maude | 2018-08-08 |
| 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 40MM +3 MAXROM LNR SZ25 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | MAY |
| Date Received | 2018-08-08 |
| Model Number | N/A |
| Catalog Number | EP-108425 |
| Lot Number | 013420 |
| Device Expiration Date | 2015-12-31 |
| 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 | 650 | 1. Hospitalization; 2. Required No Informationntervention | 2018-08-08 |