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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A TPR HI CARBON 41/32MM LNR PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A TPR HI CARBON 41/32MM LNR PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)
Event Date 06/14/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: 103535 ti low profile screw 6. 5x40mm 707940; 103534 ti low profile screw 6. 5x35mm 394800; 15-103684 m2a-t univ 2-hole shl sz 41/54 056120; 103533 ti low profile screw 6. 5x30mm 937120; 15-105044 m2a tpr hi carbon 41/32mm lnr 080230; 11-163688 32mm m2a hi carbon hd std nk 404450; 103206 taperloc por fmrl 12. 5x145 247230. The device will not be returned for analysis, as the surgeon didn't approve for return; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01933; 0001825034-2021- 01935.
 
Event Description
It was reported a patient underwent a hip arthroplasty approximately 13 years ago. Subsequently, the patient was revised approximately 2 weeks ago as the surgeon claims the patient was experiencing metal reaction related issues. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameM2A TPR HI CARBON 41/32MM LNR
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 Key12093081
MDR Text Key259202039
Report Number0001825034-2021-01934
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003363
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 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2018
Device Model NumberN/A
Device Catalogue Number15-105044
Device Lot Number080230
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 Received10/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2008
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: 06/30/2021 Patient Sequence Number: 1
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