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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 48MM PROSTHETIC, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 48MM PROSTHETIC, HIP Back to Search Results
Model Number N/A
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Host-Tissue Reaction (1297); Ossification (1428); Bacterial Infection (1735); Cyst(s) (1800); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Sepsis (2067); Osteolysis (2377); Reaction (2414)
Event Date 12/11/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unk cup, pn unknown, ln unknown, unk taper, pn unknown, ln unknown, unk stem, pn unknown, ln unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05778, 0001825034-2019-05780, 0001825034-2019-05781. 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.
 
Event Description
It was reported by patients¿ legal counsel that the patient underwent a left hip revision procedure approximately 11 years post-implantation due to metallosis, infection and sepsis, necrosis and tissue damage. Attempts were made to obtain additional information; however, none was available.
 
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Brand NameM2A-MAGNUM MOD HD SZ 48MM
Type of DevicePROSTHETIC, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9526839
MDR Text Key174259288
Report Number0001825034-2019-05779
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2016
Device Model NumberN/A
Device Catalogue Number157448
Device Lot Number458780
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/27/2019 Patient Sequence Number: 1
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