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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 3 R

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MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 3 R Back to Search Results
Catalog Number 02.09.2603R
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/15/2018
Event Type  malfunction  
Manufacturer Narrative
We immediately investigated the case and determined that a mix-up between one component of each of these two lots happened during packaging. We inspected a unit from lot 173033 in stock and found the piece from lot 173034. With this, we had full control over the two mixed components. After this confirmation, the rest of both lots were inspected to confirm that the mix-up only involved one piece from each lot and all were conforming. Batch review performed on 13 september 2018. Lot 173034: (b)(4) items manufactured and released on 02 august 2017. Expiration date: 2022-07-04. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any similar reported event. Gmk-hinge femoral component size 5 l reference 02. 09. 2605l (k130299). Lot 173033: (b)(4) items manufactured and released on 02 august 2017. Expiration date: 2022-07-04 no anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any similar reported event. Visual inspection performed by packaging and washing manager on 14 september 2018 the pictures attached to the complaint and the returned piece confirmed that there was a mix up. From a documental control it was noticed that the two lots involved in this case were consequently processed. Interviewing the operator and checking the process it is possible suppose that the two lots were packaged in the same time in the cleaning room. Due to human error, there was a mix up a piece of the two lots. The event is related to an human error, in fact the procedure reports the operators must process lots one by one.
 
Event Description
During a surgery, the box of a gmk hinge femur size 3 right (code 02. 09. 2603r - lot 173034) was opened and a gmk hinge femur size 5 left (code 02. 09. 2605l - lot 173033) was found inside. The surgeon completed the surgery implanting a gmk-hinge femoral component size 4r given that a gmk-hinge femoral component size 3r back-up was not available.
 
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Brand NameGMK-HINGE FEMORAL COMPONENT SIZE 3 R
Type of DeviceFEMORAL COMPONENT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ 6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key7876585
MDR Text Key120719110
Report Number3005180920-2018-00681
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 other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.09.2603R
Device Lot Number173034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2017
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: 09/14/2018 Patient Sequence Number: 1
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