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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50 CEMENTLESS HIP SHELL

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MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50 CEMENTLESS HIP SHELL Back to Search Results
Catalog Number 01.26.45.1150
Device Problem Component Missing
Event Date 08/30/2018
Event Type  Malfunction  
Manufacturer Narrative

Batch review performed on october 01, 2018: lot 181706: (b)(4) items manufactured and released on 30 may 2018. Expiration date: 2023-05-16. To date, (b)(4) items of the same lot have been already sold without any similar reported event. Visual inspection performed by washing and packaging manager on sep 14, 2018: through the provided pictures evaluation and the received packaging inspection it could be confirmed that the carton box was empty (the double blister and the device itself were missing). The error occurred during the packaging activities, when for the involved batch of 120 implants, the operators prepared 121 carton boxes; it was caused by a wrong management of an anomaly occurred during the packaging process and that had requested a reworking step in the clean room. The operator prepared 120 carton boxes according to route card instructions, without noticing that one implant had been moved back to be reworked; then, after reworking, the item was re-added to the involved lot and the operator packed it as well, without re-counting the total amount of the prepared carton boxes. Due to this issue, the same operator had to re-print an additional label for that device box in order to complete the packaging step: he just reported it as an "anomaly" in the route card, without trying to understand the reason for the missing label and without counting the packed boxes for that lot. In conclusion, once the lot was received back from the sterilization process, the warehouse reported in the system that 120 items were returned and stocked, but actually the total amount of implant boxes received was 121pcs.

 
Event Description

During surgery, the surgical staff opened the packaging of the acetabular shell cc trio no-hole and discovered that no implant was inside the carton box, not even the sterile plastic blisters of the implant. Only the ifu of the implant were found inside the carton box. The surgery was completed successfully with a second cup of the same size available on the consignment stock.

 
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Brand NameVERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
Type of DeviceCEMENTLESS HIP SHELL
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
  6874
MDR Report Key7929603
Report Number3005180920-2018-00739
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 10/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number01.26.45.1150
Device LOT Number181706
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/30/2018
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: 10/03/2018 Patient Sequence Number: 1
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