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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 56MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 56MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Adhesion(s) (1695); Metal Related Pathology (4530)
Event Date 11/17/2020
Event Type  Injury  
Event Description
It was reported that the patient was revised due to elevated metal ions and adverse local tissue reaction approximately 9 years post implantation. During the revision there was no significant metal debris or staining, minimal tissue necrosis, and weakened posterior capsule. The head and taper adapter were exchanged without complications. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4). Concomitant products: catalog number:139266 lot number:961790 brand name: m2a magnum tpr insrt; catalog number:157456 lot number: 814560 brand name: m2a magnum head; catalog number:us157862 lot number:315260 brand name: m2a-magnum pf cup; catalog number:192411 lot number:219480 brand name: echo por fmrl red nc. Multiple reports were submitted along with this report 0001825034-2022-00598. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
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Brand NameM2A-MAGNUM MOD HD SZ 56MM
Type of DevicePROSTHESIS, 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 Key13860633
MDR Text Key287685833
Report Number0001825034-2022-00599
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model NumberN/A
Device Catalogue Number157456
Device Lot Number814560
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2010
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: 03/23/2022 Patient Sequence Number: 1
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