MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2020-03-31 for M2A-MAGNUM MODULAR HEAD NI 157452 manufactured by Zimmer Biomet, Inc..
[187366125]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device location is unknown. Once the investigation has been completed, a follow-up mdr will be submitted concomitant medical products: part # us157858 / m2a cup / lot # 138930, part # 139270 / taper / lot # 799680, part # 12-103208 /stem/ lot # 266410. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -01400, 0001825034 -2020 -01401, 0001825034 -2020 -01403.
Patient Sequence No: 1, Text Type: N, H10
[187366126]
It was reported that patient underwent hip revision surgery 13 years post implantation due to pain and elevated metal ion levels. During the revision, the acetabular shell was found to be grossly loose with bone erosion posterior to the cup which has limited ingrowth. After additional scar tissue was removed, the stem remained intact but all other components were revised without complications. 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 | 0001825034-2020-01402 |
| MDR Report Key | 9904365 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M2A-MAGNUM MODULAR HEAD |
| Generic Name | PROSTHESIS, HIP |
| Product Code | KWA |
| Date Received | 2020-03-31 |
| Model Number | NI |
| Catalog Number | 157452 |
| Lot Number | 139710 |
| Device Expiration Date | 2016-03-30 |
| 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 | 2020-03-31 |