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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R; FIXED TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R; FIXED TIBIAL INSERT Back to Search Results
Model Number 02.12.0212FR
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/13/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 24 july 2020: lot 143385: (b)(4) items manufactured and released on 6 june 2014.Expiration date: 2019-04-30, no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2016.
 
Event or Problem Description
The patient came in 3 years and 4 months after the primary surgery for a post-op appointment and it was observed that a screw from the tibial insert had loosened.The surgeon performed a washout and revised the poly.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10354785
Report Number3005180920-2020-00510
Device Sequence Number950914
Product Code JWH
UDI-Device Identifier07630030826184
UDI-Public07630030826184
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/03/2020
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 Date04/30/2019
Device Model Number02.12.0212FR
Device Catalogue Number02.12.0212FR
Device Lot Number143385
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2020
Initial Report FDA Received Date08/03/2020
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;
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