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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED # 5/17MM; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED # 5/17MM; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.07.0517PSF
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/12/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Batch review performed on 11 december 2018; lot 179577: (b)(4) items manufactured and released on 1 march 2018.Expiration date: 2023-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
During the primary knee surgery, the surgeon was unable to engage the tibial insert screw into the tibial baseplate.The surgeon closed up the patient without the screw.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT PS FIXED # 5/17MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8150509
Report Number3005180920-2018-00988
Device Sequence Number13515903
Product Code JWH
UDI-Device Identifier07630030818547
UDI-Public07630030818547
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/11/2018
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
Operator of Device Health Professional
Device Expiration Date01/31/2023
Device Catalogue Number02.07.0517PSF
Device Lot Number179577
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/12/2018
Initial Report FDA Received Date12/11/2018
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 Other;
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