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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENDER SOLUTIONS NATURAL KNEE SYSTEM PROLONG HIGHLY CROSSLINKED POLYETHYLENE PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. GENDER SOLUTIONS NATURAL KNEE SYSTEM PROLONG HIGHLY CROSSLINKED POLYETHYLENE PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 02/14/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Additional concomitant medical products: n-k flex porous femoral component, catalog #: 00541201601, lot #: 62080687; nkii tibial plated, catalog #: 630700220, lot #: 62053467. (b)(6). Customer has indicated product will not be returned as product location is unknown. The investigation is in process. Once the investigation is completed, a follow-up report will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00852, 0001822565-2019-00853, 0001822565-2019-00854. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Product location unknown.

 
Event Description

It was reported patient underwent left total knee arthroplasty. Subsequently, patient was revised due to loosening, pain, and decreased range of motion.

 
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Brand NameGENDER SOLUTIONS NATURAL KNEE SYSTEM PROLONG HIGHLY CROSSLINKED POLYETHYLENE
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 Key8369494
MDR Text Key137118868
Report Number0001822565-2019-00854
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK071107
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 08/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2017
Device MODEL NumberN/A
Device Catalogue Number00542401109
Device LOT Number62130345
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 Received08/22/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/03/2012
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: 02/26/2019 Patient Sequence Number: 1
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