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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M2A MAGNUM ACETABULAR COMPONENT PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN M2A MAGNUM ACETABULAR COMPONENT PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Wound Dehiscence (1154)
Event Date 06/02/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr's were reported for this event. Please also see associated events: 0001825034 - 2018 - 02634. Report source: literature: gaillard, melissa d. , gross, thomas p (2017). Metal-on-metal hip resurfacing in patients younger than 50 years: a retrospective analysis. Journal of orthopaedic surgery and research, 12(79). Doi: 10. 1186/s13018-017-0579-y the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported in a journal article, patients underwent reoperation following hip resurfacing arthroplasty. Four patients underwent reoperation due to wound dehiscence.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this report is a duplicate of a previously submitted medwatch form. The initial report was forwarded in error and should be voided.
 
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Brand NameUNKNOWN M2A MAGNUM ACETABULAR COMPONENT
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 Key7431057
MDR Text Key105513455
Report Number0001825034-2018-02635
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/13/2018 Patient Sequence Number: 1
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