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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, LEFT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT, LEFT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Naturally Worn (2988)
Patient Problems Damage to Ligament(s) (1952); Pain (1994); Swelling (2091); Reaction (2414)
Event Date 12/16/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4) concomitant medical products: 00542801009, bearing, 61136943. 00542000800, patella, 61621399. 642000100, tibial tray, 61493582. The articular surface was returned for further analysis. The articular surface fractured on the medial side. Burnishing and abrasion were identified on the lateral side. Sem analysis demonstrated that damage observed is consistent with typical in vivo use, from explantation damage, and of potential overloading. The dhr was reviewed and no discrepancies relevant to the reported event were found. Initial op notes demonstrated that the patient had left tka due to osteoarthritis. Revision op notes demonstrated that the patient was revised due to articular surface fracture, and metal wear debris synovitis and effusion. The patient experienced instability, catching, swelling, and stiffness. The diagnosis was again pes anserinus and the patient had an injection. Patient is allergic to nickel. No infection was found upon aspiration. Wear was noted through the poly. There was a fracture in the poly posteromedially and that there was scratching of the metal femoral component over the medial femoral condyle. There were 3 cysts noted around the tibial plateau. Bone cement was identified on the tibial and femoral components. Minor scratches were identified in the lateral side and more were identified on the medial side of the femoral component. A definitive root cause cannot be determined. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01540, 0001822565 - 2019 - 01544.

 
Event Description

It was reported that the patient underwent left knee revision approximately 5 years post implantation due to pain, swelling, stiffness, instability, ligament laxity, and poly wear and fracture. The patient is also allergic to nickel.

 
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Brand NameGENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT, LEFT
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 Key9963060
MDR Text Key193264781
Report Number0001822565-2019-01543
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK173057
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 04/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00541401401
Device LOT Number61789863
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/29/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/14/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/13/2011
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: 04/15/2020 Patient Sequence Number: 1
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