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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEGMENTAL DISTAL FEMORAL COMPONENT PROSTHESIS KNEE

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ZIMMER BIOMET, INC. SEGMENTAL DISTAL FEMORAL COMPONENT PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/23/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical product: segmental polyethylene insert catalog # 00585001295 lot # 62271451; segmental articular surface catalog # 00585002012 lot # 62949396; segmental fluted stem extension straight precoat catalog # 00585205014 lot # 62032778. Stem collar 25 mm o. D. For use with 16 mm or smaller diameter segmental stems catalog # 00585204025 lot # 61960736. Report source: (b)(6). Customer has indicated that the product will not be returned because it was discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filled for this event: 0001822565-2021-01605. Discarded.
 
Event Description
It was reported that the patient underwent a revision due to loosening. The surgeon removed existing implants and replaced with new. Attempt for further information has been made, but no further information has been provided.
 
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Brand NameSEGMENTAL DISTAL FEMORAL COMPONENT
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 Key11975138
MDR Text Key255399637
Report Number0001822565-2021-01602
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K070978
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 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00585001202
Device Lot Number62978969
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 Received07/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2015
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: 06/10/2021 Patient Sequence Number: 1
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