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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Numbness (2415)
Event Date 06/17/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 00542801013 - articular surface - 60988242; 00542000800 - patella - 61924087; 630700200 - tibial tray - 61927583. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02495.

 
Event Description

It was reported that the patient underwent left knee revision approximately 8 years post implantation due to pain and dislocation of the poly.

 
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Brand NameGENDER SOLUTIONS FEMALE (GSF) 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 Key10250362
MDR Text Key198115356
Report Number0001822565-2020-02496
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK071107
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 07/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00541401501
Device LOT Number61894475
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 Received06/19/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/17/2011
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: 07/09/2020 Patient Sequence Number: 1
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