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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S7 RM
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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S7 RM Back to Search Results
Model Number 02.18.007RM
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 09/30/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 october 2021.Lot 167881: (b)(4) items manufactured and released on 21-feb-2017.Expiration date: 2022-02-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
At 3 years and 4 months after the primary the patient came in reporting pain due to a loose femur and the cause of the loose femur is unknown.The surgeon revised the femoral component, tibial tray, and insert.The surgery was completed successfully.
 
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Brand Name
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S7 RM
Common Device Name
ANATOMICAL FEMORAL COMPONENT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12711333
Report Number3005180920-2021-00838
Device Sequence Number4985176
Product Code HSX
UDI-Device Identifier07630030895661
UDI-Public07630030895661
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K162084
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/28/2021
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? No
Operator of Device Health Professional
Device Expiration Date02/06/2022
Device Model Number02.18.007RM
Device Catalogue Number02.18.007RM
Device Lot Number167881
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2021
Initial Report FDA Received Date10/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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