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 2020-02-24 for ECHO POR FMRL NC 12X140MM N/A 192012 manufactured by Zimmer Biomet, Inc..
[187022983]
(b)(4). Concomitant medical products: us157854 m2a-magnum pf cup 54odx48id 302240; 157448 m2a-magnum mod hd sz 48mm 48mm 339660; 139258 m2a-magnum 42-50m tpr 880580. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. 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: 0001825034-2020-00862 insert.
Patient Sequence No: 1, Text Type: N, H10
[187022984]
Patient? S legal counsel reported patient underwent right total hip arthroplasty. The patient was revised seven years later due to cup migration, altr, and corrosion. During the surgery, it was discovered that the insert and stem had cold welded together and would not separate. While trying to remove the femoral components, the femur was fractured. Attempts were made to obtain additional information; however, none was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-00863 |
| MDR Report Key | 9746362 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2016-03-04 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2008-10-31 |
| Date Added to Maude | 2020-02-24 |
| 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 | ECHO POR FMRL NC 12X140MM |
| Generic Name | PROSTHESIS, HIP |
| Product Code | KWZ |
| Date Received | 2020-02-24 |
| Model Number | N/A |
| Catalog Number | 192012 |
| Lot Number | 267000 |
| Device Expiration Date | 2018-10-31 |
| 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. Required No Informationntervention | 2020-02-24 |