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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Erosion (1750); Pain (1994); Local Reaction (2035); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)
Event Date 03/10/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: 192011, echo por fmrl nc, 11x135mm, 555530; 139254, m2a-magnum 42-50mm, tpr insrt-3, 452410; us157852, m2a-magnum pf cup, 52odx46id, 691000. 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 - 02468.
 
Event Description
It was reported that the patient had an initial left hip replacement. The patient was revised ten years later due to pain, metal pathology, osteolysis and ambulation difficulties. The head, liner and cup were revised. Patient states that she is still experiencing pain and limited mobility. No additional information is available.
 
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Brand NameM2A-MAGNUM MOD HD SZ 46MM
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 Key10189513
MDR Text Key196745410
Report Number0001825034-2020-02469
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 consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
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 Number157446
Device Lot Number983650
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 Received08/07/2020
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: 06/24/2020 Patient Sequence Number: 1
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