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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 18 HOLES, 355 MM; PROSTHESIS, TRAUMA

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ZIMMER GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 18 HOLES, 355 MM; PROSTHESIS, TRAUMA Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 01/17/2024
Event Type  Injury  
Manufacturer Narrative
(b)(4).G2.Report source: australia.No product was returned, however a picture was provided.The pictures shows the explanted plate and 3 screws.As the plate appears to be fractured, event can be confirmed.A review of the device manufacturing records could not be performed due to missing lot number.Device is used for treatment.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Review of the complaint history identified additional similar complaints for the reported item.However, due to the lack of the lot number, an additional lot search could not be performed.Complaints are monitored per complaint trending process in order to identify potential adverse trends.The provided radiographed were reviewed from a radiologist.Plate and screw fixation are visible along the lateral aspect of the left femur, with an oblique distal femoral diaphyseal fracture noted.There is a fracture of the plate at the level of the osseous fracture, with fracture lucency remaining and slight lateral bowing of the femur centered at the level of the plate fracture.The fixation screws appear intact.Bone quality is markedly osteopenic.As there are no other femur fractures identified along the visualized fixation plate, it is suspected that this fracture represents non-union of the original femur fracture.This could be confirmed by correlation with earlier images before plate and screw fixation.With the available information, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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 broken left distal ncb periprosthetic plate approximately 5 months post implantation.Plate has broken for no apparent reason that the surgeon knows of.Underlying fracture does not seem to have united since initial plating.Patient underwent a revision surgery.Diligence is complete and to date no additional information is available.
 
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Brand Name
NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 18 HOLES, 355 MM
Type of Device
PROSTHESIS, TRAUMA
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ   8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key18670765
MDR Text Key334920710
Report Number0009613350-2024-00038
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K100111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue Number0202264118
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/17/2024
Initial Date FDA Received02/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age91 YR
Patient SexMale
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