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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. FEMORAL HINGE SERVICE KIT; PROSTHESIS, KNEE

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ZIMMER, INC. FEMORAL HINGE SERVICE KIT; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2017
Event Type  malfunction  
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.
 
Event Description
It is reported that while the surgeon was torquing the locking nut on the hinge pin, it stripped out.The surgeon completed the surgery with a different locking nut.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Manufacturer Narrative
Visual inspection of the returned components found that the device shows scratches and burrs.Dimensional analysis of the device cannot be performed as the set screw is stripped.Sterigenics certificate shows all devices were sterilized per specifications.This event is related to a stand-alone implant; therefore, implant compatibility is not applicable.Surgical notes were not provided, but it was reported that the proper surgical technique was employed.A definitive root cause cannot be determined with the information 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.
 
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Brand Name
FEMORAL HINGE SERVICE KIT
Type of Device
PROSTHESIS, 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 Key6564325
MDR Text Key75103192
Report Number0001822565-2017-03269
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK150028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2023
Device Model NumberN/A
Device Catalogue Number00585007112
Device Lot Number63379305
Other Device ID Number(01)008889024196315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/15/2017
Initial Date FDA Received05/12/2017
Supplement Dates Manufacturer ReceivedNot provided
01/25/2018
Supplement Dates FDA Received05/30/2017
01/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2016
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 Age74 YR
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