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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R; CEMENTED FEMORAL COMPONENT
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MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R; CEMENTED FEMORAL COMPONENT Back to Search Results
Model Number 02.12.0004R
Medical Device Problem Code Malposition of Device (2616)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 07/01/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 july 2021.Lot 2010164: (b)(4) items manufactured and released on 01-feb-2021.Expiration date: 2026-01-13.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 or Problem Description
2 days after the primary the patient came in reporting pain and the surgeon observed that the patient was in excessive valgus.The surgeon revised the femoral component, patella, and insert.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R
Common Device Name
CEMENTED FEMORAL COMPONENT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12187885
Report Number3005180920-2021-00614
Device Sequence Number1322753
Product Code JWH
UDI-Device Identifier07630030825842
UDI-Public07630030825842
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/19/2021
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 Date01/13/2026
Device Model Number02.12.0004R
Device Catalogue Number02.12.0004R
Device Lot Number2010164
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/01/2021
Initial Report FDA Received Date07/19/2021
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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