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 2020-03-30 for M2A-MAGNUM MOD HD SZ 44MM N/A 157444 manufactured by Zimmer Biomet, Inc..
[186673173]
(b)(4). Concomitant medical products: us157850-m2a-magnum pf cup 50odx44id-817190, 139254-m2a-magnum 42-50mm tpr insrt-3-870720. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01324. Customer has indicated that the product will not be returned to zimmer biomet for investigation, patient kept devices. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Patient kept devices.
Patient Sequence No: 1, Text Type: N, H10
[186673174]
It was reported that patient underwent a revision procedure approximately 12 years post-implantation due to elevated metal ion levels. During the procedure the magnum head was explanted along with the magnum stem. Surgeon kept the magnum cup implanted. 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 | 0001825034-2020-01326 |
| MDR Report Key | 9897148 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2020-03-30 |
| 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 | M2A-MAGNUM MOD HD SZ 44MM |
| Generic Name | PROSTHESIS, HIP |
| Product Code | KWA |
| Date Received | 2020-03-30 |
| Model Number | N/A |
| Catalog Number | 157444 |
| Lot Number | 639850 |
| Device Expiration Date | 2018-04-30 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-30 |