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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 62ODX56ID PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 62ODX56ID PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Wound Dehiscence (1154)
Event Date 12/15/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Catalog number: 192411 lot number:219480 brand name: (b)(4). Catalog number:us157862 lot number:315260 brand name: (b)(4). Catalog number:650-1065 lot number:unknown brand name: (b)(4). Catalog number:110031006 lot number:unknown brand name: (b)(4). Catalog number:650-1055 lot number:unknown brand name: (b)(4). Multiple reports were submitted along with this report: 0001825034-2022-00607. 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 that the patient was revised due to wound dehiscence and deep hip seroma with swelling and serosanguineous fluid approximately 2 weeks post revision surgery. During the revision tissue sent for cultures, results pending, and debridement of adhesions. Wound vac placed and iv antibiotics until culture is negative. Stopped dvt anticoagulants due to wound complications. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameM2A-MAGNUM PF CUP 62ODX56ID
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 Key13826339
MDR Text Key287695213
Report Number0001825034-2022-00608
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 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2021
Device Model NumberN/A
Device Catalogue NumberUS157862
Device Lot Number315260
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2011
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: 03/19/2022 Patient Sequence Number: 1
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