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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN ROTATING HINGE ARTICULAR SURFACE PROSTHESIS, KNEE

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ZIMMER, INC. NEXGEN ROTATING HINGE ARTICULAR SURFACE PROSTHESIS, KNEE Back to Search Results
Catalog Number 00588006014
Device Problems Detachment Of Device Component (1104); Disassembly (1168); Material Erosion (1214); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Loss of Range of Motion (2032); No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2017
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. It was reported that a patient was revised to address a damaged mechanism. A screw was noted to be disassembled and damage was noted to the femur and articular surface. No additional information is known at this time. Implant date - (b)(6) 2013. Explant date - (b)(6) 2017. Concomitant medical products - palacos cement catalog b6031993 lot 76054329, palacos cement catalog b6031993 lot 75554341, nexgen articular surface catalog 00588006014 lot 62157558, nexgen stem extension catalog 00598801014 lot 62389721, nexgen femur catalog 00588001601 lot 61958393, nexgen stem extension catalog 00598801015 lot 62339053, synplug size 16 reference 804022 lot 2008658.
 
Event Description
It was reported that a patient was revised to address a damaged mechanism. A screw was noted to be disassembled and damage was noted to the femur and articular surface. No additional information is known at this time.
 
Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown a the time of the initial medwatch. The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch will be submitted.
 
Manufacturer Narrative
(b)(4). 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.
 
Event Description
It was further reported that the patient had hinge dismantled pain, blockage, instability, and heard a noise.
 
Manufacturer Narrative
(b)(4). Reported event is considered confirmed as visual examination showed signs of that the hinge post and hinge post extension had fractured threads. The poly box insert was deformed and the femoral component had a foreign material on the surface. Fracture analysis of the hinge post revealed a suspected overload fracture. Device history record was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. 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.
 
Manufacturer Narrative
(b)(4). 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. 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.
 
Event Description
It was reported that a patient was revised to address a damaged mechanism. Attempts have been made and no further information has been provided.
 
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Brand NameNEXGEN ROTATING HINGE ARTICULAR SURFACE
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6669186
MDR Text Key109660331
Report Number0001822565-2017-04433
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PK013385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2017
Device Catalogue Number00588006014
Device Lot Number62157558
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2017 Patient Sequence Number: 1
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