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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 6 R

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MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 6 R Back to Search Results
Catalog Number 02.09.2606R
Device Problems Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2019
Event Type  malfunction  
Manufacturer Narrative
Batch review performed on 05 february 2019: lot 177961: (b)(4) items manufactured and released on 05-jan-2018. Expiration date: 2022-12-11. 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. Investigation performed by washing and packaging manager: in the pictures received the inner blister containing the involved femoral components is cracked moreover, the carton box also shows signs of damage. According to internal procedures, the operator involved in the manufacturing process must 100% check the integrity of the whole package of each single item of the lot. Considering that it is implausible for the device to be released with such damage by medacta international (b)(4), the two following root causes could be evaluated: anomalous shipping conditions: considering the extent of the breakage, it can be reasonably excluded that the damage could have been generated by standard shipping methods. Accidental handling damage: it is possible that during handling/storage at the hospital an accidental event occurred resulted in the damage. Considering the points above, the most probable root cause could be found in accidental shipping/ handling damage. Only the implant was received for the investigation (packaging was not returned). From the returned device no visual inspection is possible because the packaging was not received.
 
Event Description
During the primary knee surgery, it was discovered that the size 6 femoral component packaging (blister and box) was damaged and the sterility was compromised. There was not another size 6 femoral component available and the surgeon had to use a size 5 instead. This caused an hour and a half delay in the case, anyway the surgery was completed successfully.
 
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Brand NameGMK-HINGE FEMORAL COMPONENT SIZE 6 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 Key8310183
MDR Text Key137547452
Report Number3005180920-2019-00025
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.09.2606R
Device Lot Number177961
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2018
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: 02/06/2019 Patient Sequence Number: 1
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