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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN ROTATING HINGE KNEE FEMORAL COMPONENT OPTION SIZE C RIGHT PROSTHESIS, KNEE

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ZIMMER, INC. NEXGEN ROTATING HINGE KNEE FEMORAL COMPONENT OPTION SIZE C RIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Ossification (1428); No Code Available (3191)
Event Date 11/30/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: item name: prc agmt block dist sz c 5mm, item number: 00599003310*op1000, lot number: 60969421. Item name: prc agmt block dist sz c 5mm, item number: 00599003310*op1000, lot number: 61173797. Item name: articular surface hinge post extension size c 14 mm, item number: 00588003014, lot number: 61091165. Item name: tibial component precoat size 2, item number: 00588000200, lot number: 61170223. Item name: stem extension sharp fluted 11mm dia x 75mm length, item number: 00598801511, lot number: 607885156. Item name: stem extension straight long 14mm dia x 155mm length(combined length 200mm), item number: 00598801114, lot number: 60372674. Report source:- (b)(6). No product was returned. Visual and dimensional evaluations could not be performed. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required. Based on the information available, a definitive root cause cannot be determined. 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: 0001822565-2017-05573, 0001822565-2017-05576, 0001822565-2017-05575, 0001822565-2016-04777.
 
Event Description
It was reported that patient was revised due to a fracture of the femoral shaft approximately seven years post implantation. X-rays indicated slight anterior displacement of the distal femoral component, osseous radiolucency of lateral femoral condyle, radiolucency at the tibial tray, tibial stem shows loosening, and generalized osteopenia and heterotopic ossifications.
 
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Brand NameNEXGEN ROTATING HINGE KNEE FEMORAL COMPONENT OPTION SIZE C RIGHT
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 Key6779002
MDR Text Key82403874
Report Number0001822565-2017-05575
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2013
Device Model NumberN/A
Device Catalogue Number00588001302
Device Lot Number61077463
Other Device ID NumberN/A
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 Received07/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2008
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: 08/09/2017 Patient Sequence Number: 1
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