MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL 54

Model Number	01.26.45.0054
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2020: lot 2000133: (b)(4) items manufactured and released on 17-june-2020.Expiration date: 2025-06-03.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.Clinical evalaution: few weeks after primary tha in a dysplastic hip, the cup mobilizes.It did not achieve good primary stability, for reasons that could not be ascertained with the information at hand.No reason to suspect that the device was defective.
Event or Problem Description
Revision surgery 4 weeks after primary surgery due to cup migration.The patient has ddh (developmental dysplasia of the hip).The revision was performed successfully, only acetabular components swapped with competitor devices.The stem was well fixed.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL 54
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10928261
• Report Number: 3005180920-2020-00849
• Device Sequence Number: 13650839
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• Combination Product (Y/N): Y
• Initial Reporter Country: IS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2025
• Device Model Number: 01.26.45.0054
• Device Catalogue Number: 01.26.45.0054
• Device Lot Number: 2000133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Weight: 60