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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 LM - 10MM
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MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 LM - 10MM Back to Search Results
Model Number 02.18.IF2.10.LM
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 05/11/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 may 2020: lot 172346: (b)(4) items manufactured and released on 24-oct-2017.Expiration date: 2022-10-11.No anomalies found related to the problem.To date, 4 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in, 9 months after primary surgery, reporting tightness of the knee.The surgeon revised the 10mm poly with an 8mm poly and the surgery was completed successfully.
 
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Brand Name
MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 LM - 10MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10127318
Report Number3005180920-2020-00312
Device Sequence Number2256237
Product Code HSX
UDI-Device Identifier07630030895890
UDI-Public07630030895890
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K162084
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/08/2020
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 Date10/11/2022
Device Model Number02.18.IF2.10.LM
Device Catalogue Number02.18.IF2.10.LM
Device Lot Number172346
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/11/2020
Initial Report FDA Received Date06/08/2020
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;
Patient Age71 YR
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