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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 SIZE 2/17MM; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 2/17MM; KNEE TIBIAL INSERT Back to Search Results
Model Number 02.07.0217PSF
Health Effect - Clinical Code Loss of Range of Motion (2032)
Date of Event 08/02/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 august 2021: lot 166096: (b)(4) items manufactured and released on 17-nov-2016.Expiration date: 2021-11-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.
 
Event or Problem Description
10 months after the previous surgery the patient came in reporting stiffness in the knee and the cause of the stiffness is unknown.The surgeon revised insert 17mm s2 with an insert 10mm s2.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 2/17MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12390639
Report Number3005180920-2021-00691
Device Sequence Number5087846
Product Code JWH
UDI-Device Identifier07630030816802
UDI-Public07630030816802
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/31/2021
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 Date11/02/2021
Device Model Number02.07.0217PSF
Device Catalogue Number02.07.0217PSF
Device Lot Number166096
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/02/2021
Initial Report FDA Received Date08/31/2021
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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