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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/17MM

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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/17MM Back to Search Results
Model Number 02.09.0417H
Device Problem Material Rupture (1546)
Patient Problem Damage to Ligament(s) (1952)
Event Date 07/09/2021
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 20 july 2021: lot 189417: (b)(4) items manufactured and released on 12-feb-2019. Expiration date: 2024-01-27. 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 Description
The patient had a primary and was implanted with competitor implants. On (b)(6) 2019, the patient came in and had the competitor components revised to medacta for reasons unknown. The surgery was completed successfully. On (b)(6) 2021, 1 year and 11 months after hinge implantation the patient came in reporting pain due to a ruptured quad tendon. The cause of the ruptured quad tendon is unknown. The surgeon performed a quad tendon repair and revised the poly. The surgery was completed successfully.
 
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Brand NameGMK-HINGE FIXED TIBIAL INSERT SIZE 4/17MM
Type of DeviceTIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 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 Key12217045
MDR Text Key263123935
Report Number3005180920-2021-00632
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number02.09.0417H
Device Catalogue Number02.09.0417H
Device Lot Number189417
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/12/2019
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: 07/23/2021 Patient Sequence Number: 1
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