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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM M2A HI CARBON HD +3MM NK PROSTHESIS, HIP

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ZIMMER BIOMET, INC. 32MM M2A HI CARBON HD +3MM NK PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/15/2021
Event Type  Injury  
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 devices: part: 10-104052, lot: 321840, m2a-t m/h rad 2hl shl 41/52mm; part: 15-105044, lot: 896550, m2a tpr hi carbon 41/32mm lnr. Report source: (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02180, 0001825034-2021-02179.
 
Event Description
It was reported that the patient was revised 12 years post-implantation due to possible pseudotumor. Attempts have been made and no further information has been provided.
 
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Brand Name32MM M2A HI CARBON HD +3MM NK
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 Key12204605
MDR Text Key262873617
Report Number0001825034-2021-02177
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K003363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2018
Device Model NumberN/A
Device Catalogue Number11-163689
Device Lot Number135910
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 Received10/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2008
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

Patient Treatment Data
Date Received: 07/21/2021 Patient Sequence Number: 1
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