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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 R; CEMENTED KNEE FEMUR
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MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 R; CEMENTED KNEE FEMUR Back to Search Results
Catalog Number 02.07.2204R
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/12/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 october 2018: lot 125530: (b)(4) items manufactured and released on 01 march 2013.Expiration date: 2018-01-31.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
The patient came in complaining of pain 4 years after primary.The surgeon determined that the femur was loose.The surgeon revised the femur, patella and insert.The surgery was completed successfully.
 
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Brand Name
GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 R
Common Device Name
CEMENTED KNEE FEMUR
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7956125
Report Number3005180920-2018-00776
Device Sequence Number10813759
Product Code JWH
UDI-Device Identifier07630030820854
UDI-Public07630030820854
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/11/2018
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 Date01/31/2018
Device Catalogue Number02.07.2204R
Device Lot Number125530
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/12/2018
Initial Report FDA Received Date10/11/2018
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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