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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEG HINGE POST, SZ F 14MM 3DEG PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. SEG HINGE POST, SZ F 14MM 3DEG PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
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 remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Additional associated products & mdrs: 32855411128, seg art surf sz f 14mm 3deg, lot# 95002187. Mdr: 0001822565-2021-03698.
 
Event Description
It was reported the patient is experiencing some anterior knee pain, worse with activity dur to wear. A future revision is being planned, and a replacement custom poly and hinge post to match the existing custom implants is required. No date for the revision has been set at this time.
 
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Brand NameSEG HINGE POST, SZ F 14MM 3DEG
Type of DevicePROSTHESIS, KNEE
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 Key13569802
MDR Text Key288363077
Report Number0001822565-2022-00537
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070978
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00855480775
Device Lot Number95002186
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2008
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

Patient Treatment Data
Date Received: 02/21/2022 Patient Sequence Number: 1
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