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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 5 R; KNEE FEMORAL COMPONENT
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MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R; KNEE FEMORAL COMPONENT Back to Search Results
Model Number 02.12.0005R
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 07/02/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 july 2021: lot 1903613: 64 items manufactured and released on 30-jul-2019.Expiration date: 2024-07-21.No anomalies found related to the problem.To date, 59 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in reporting pain due to a loose femur and the cause of the loose femur is unknown.The surgeon revised the femoral component and poly 4 months and 1 week after primary.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
Common Device Name
KNEE FEMORAL COMPONENT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12224563
Report Number3005180920-2021-00616
Device Sequence Number4440636
Product Code JWH
UDI-Device Identifier07630030825866
UDI-Public07630030825866
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) 07/26/2021
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 Date07/21/2024
Device Model Number02.12.0005R
Device Catalogue Number02.12.0005R
Device Lot Number1903613
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/02/2021
Initial Report FDA Received Date07/26/2021
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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