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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL TRAY SIZE 1 R

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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL TRAY SIZE 1 R Back to Search Results
Model Number 02.09.4001R
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 03/01/2022
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 25 march 2022: lot 120877: (b)(4) items manufactured and released on 19-jun-2012. Expiration date: 2017-05-31. 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 since 2018. Additional item involved in the event, batch review performed on 25 march 2022: gmk-hinge 02. 09. 0112h fixed tibial insert size 1/12mm (k130299) lot. 143001. Lot 143001: (b)(4) items manufactured and released on 28-aug-2014. Expiration date: 2019-06-30. 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 since 2018.
 
Event Description
The patient came in reporting pain and the cause of the pain is unknown. The surgeon revised the competitor patella, medacta tibial tray, and medacta poly 4 years and 11 months after primary. The surgery was completed successfully.
 
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Brand NameGMK-HINGE FIXED TIBIAL TRAY SIZE 1 R
Type of DeviceFIXED TIBIAL TRAY
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
CH 6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key13963189
MDR Text Key288274023
Report Number3005180920-2022-00208
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130299
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2017
Device Model Number02.09.4001R
Device Catalogue Number02.09.4001R
Device Lot Number120877
Was Device Available for Evaluation? No
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/19/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/31/2022 Patient Sequence Number: 1
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