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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENDER SOLUTIONS MALE (GSM) FEMORAL COMPONENT POROUS; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. GENDER SOLUTIONS MALE (GSM) FEMORAL COMPONENT POROUS; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Bone Fracture(s) (1870)
Event Date 10/23/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical product: rotating platform articular surface ultra congruent size 3 right 9 mm height item# 00543202309, lot# 61723264.Porous tibial baseplate size 3, right, item# 630803301, lot# 61534329.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient was revised approximately two years and one-month post implantation due to femoral loosening.The patient fell on the glass and there was a femoral fracture above the prosthesis that was treated by nailing.The fracture has consolidated but has loosened the femoral piece of the prosthesis.There is no additional information available at this time.
 
Manufacturer Narrative
Upon receipt of additional information it was determined that this item was reported in error.Additional information received indicates this event is not related to an issue with the implanted product.The surgeon attributes the cascade of events to the fracture sustained from falling on the ice that resulted in altered bone healing / patient anatomy complications.
 
Event Description
Upon receipt of additional information it was determined that this item was reported in error.Additional information received indicates this event is not related to an issue with the implanted product.The surgeon attributes the cascade of events to the fracture sustained from falling on the ice that resulted in altered bone healing / patient anatomy complications.
 
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Brand Name
GENDER SOLUTIONS MALE (GSM) FEMORAL COMPONENT POROUS
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10363680
MDR Text Key201610362
Report Number0001822565-2020-02646
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
PMA/PMN Number
K071107
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2020
Device Model NumberN/A
Device Catalogue Number00541201602
Device Lot Number61590798
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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