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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE PROSTHESIS, KNEE

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ZIMMER, INC. NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE PROSTHESIS, KNEE Back to Search Results
Catalog Number 00588006014
Device Problems Material Erosion (1214); Appropriate Term/Code Not Available (3191)
Patient Problem Limited Mobility Of The Implanted Joint (2671)
Event Date 02/22/2017
Event Type  Injury  
Manufacturer Narrative
The follow-up report is being submitted to relay additional information. Concomitant medical product: nexgen all polyethylene patella, cat#: 00597206535 lot#: 62793817, nexgen rotating hinge knee femoral, cat#: 00588001601 lot#: 62502480, nexgen straight stem extension, cat#: 00598801012 lot#: 37215178, nexgen tibial tray, cat#: 00588000600 lot#: 62788361, nexgen straight long stem extension, cat#: 00598801114 lot#: 00370899. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-01631, 0002648920-2017-00685, 0001822565-2017-07706.
 
Event Description
It was reported the patient underwent a total knee arthroplasty. Subsequently, the patient underwent a revision procedure approximately two years post-implantation due to locking knee and hyperextending joint. It was indicated that the problem could be a result of damage to the hinge pin. The surgeon indicated that during the revision the pin was noted to be loose. He also noted that there was wear of the polyethylene bearing and the patella button. No additional patient consequences were reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was confirmed by x-ray review. X-ray review states that left total knee arthroplasty complicated by damaged anterior tilted hinge pin and metallosis. Possible contributing factor to hinge pin malalignment is malalignment of the tibial component which lacks desirable posterior slope. However, the wear of the device can't be observed via x-ray. Device history record was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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 the patient underwent a total knee arthroplasty. Subsequently, the patient underwent a revision procedure approximately two years post-implantation due to locking knee and hyperextending joint. It was indicated that the problem could be a result of damage to the hinge pin. The surgeon indicated that during the revision the pin was noted to be loose. He also noted that there was wear of the polyethylene bearing and the patella button. Metallosis was found by third party x-ray review. No additional patient consequences were reported.
 
Manufacturer Narrative
(b)(6). Implant date - it was reported that it was approximately two years ago. (b)(4). It is unknown if product will be returning to zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that patient is scheduled for a revision due to a locking knee and hyperextending joint. It was indicated the problem might be due to damage to the hinge pin.
 
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Brand NameNEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
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 Key6392222
MDR Text Key120143873
Report Number0001822565-2017-01631
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
PK013385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Catalogue Number00588006014
Device Lot Number62207488
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2012
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: 03/09/2017 Patient Sequence Number: 1
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