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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-6 HIP PROSTHESIS

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ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-6 HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Separation Failure (2547)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # (b)(4), magnum trispike cup, lot # 264460, item #(b)(4), m2a-magnum mod hd, lot # 563840, item #(b)(4), mlry-hd lat por fmrl, lot # 303380.
 
Event Description
It was reported that the femoral head would not disengage during revision. No impact or harm to patient has been reported. Attempts have been made, and no further information has been provided.
 
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Brand NameM2A-MAGNUM 42-50MM TPR INSRT-6
Type of DeviceHIP PROSTHESIS
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 Key8206311
MDR Text Key131722927
Report Number0001825034-2018-11521
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2018
Device Model NumberN/A
Device Catalogue Number139252
Device Lot Number920510
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 Received08/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2008
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

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