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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LEFT SIZE 3 PRECOAT CEMENTED PATELLO-FEMORAL TROCHLEA COMPONENT; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. LEFT SIZE 3 PRECOAT CEMENTED PATELLO-FEMORAL TROCHLEA COMPONENT; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Detachment of Device or Device Component (2907); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 08/16/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03061,.
 
Event Description
It was reported that the patient underwent a knee revision approximately 8 years post implantation due to pain, cracking noise, loss of mobility, and disassociation.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
 
Event Description
It was reported that the patient underwent an initial left total knee arthroplasty.Approximately 8 years post implantation, the patient was revised due to pain, noise, difficulty ambulating, implant 'coming apart', decreased adls, and loosening.
 
Event Description
It was reported by the patient that they underwent an initial left knee arthroplasty where they had a patellofemoral replacement.Subsequently, the patient was revised approximately 8 years post implantation due to pain, cracking noise, loss of mobility, and the implant 'coming apart'.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component (annex g) code is mechanical (g04) - femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified that the patient was experiencing pain, cracking noise and loss of mobility.But no revision ops notes was provided.After revision, the patient was healed and post-ops x-ray found no loosening.Pre-op x-ray was reviewed and found loose patellofemoral joint.A definitive root cause cannot be determined.Per package insert, loosening is known risk of the system.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
LEFT SIZE 3 PRECOAT CEMENTED PATELLO-FEMORAL TROCHLEA COMPONENT
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key15669251
MDR Text Key302374436
Report Number0001822565-2022-03062
Device Sequence Number1
Product Code KRR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070695
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 02/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2024
Device Model NumberN/A
Device Catalogue Number00592601301
Device Lot Number62605487
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2014
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 SexFemale
Patient Weight78 KG
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