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

Catalog Number	01.26.45.1150
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2019: lot 172698: (b)(4) items manufactured and released on 19-sep-2017.Expiration date: 2022-09-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Batch review performed by the ceramic liner manufacturer ceramtec: implants from ceramtec 38.49.7188.545.20 ceramic liner ø 36 / e lot.7011143368 (not registered in us): due to lack of information about the laser engraving, the identification of the insert is only possible based on the information provided by medacta.The insert belongs to the shop order (b)(4).Protocols and certificate of conformance were reviewed.The quality documents (including the sterilization certificates) show that the values obtained on the insert were according to the specification valid at the time of the production.Conclusions: the component properties and the microstructure as obtained from the quality documents fulfill the requirements as specified at the time of production.There are no indications of any pre-existing material defects or non-conformances regarding sterilization.Due to the lack of ceramic parts further investigations cannot be done.Clinical evaluation performed by medical affairs department late infection in cementless tha, 1.5 years after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
Revision surgery performed after 1,5 years from the primary due to a septic infection.The surgery was completed successfully: ablation of the acetabulum and the liner.The surgeon couldn't remove the stem (despite the using of the extractor) he decided to leave it in place.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL NO-HOLE Ø 50
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8649829
• Report Number: 3005180920-2019-00427
• Device Sequence Number: 2129959
• Product Code: LZO
• UDI-Device Identifier: 07630030807886
• UDI-Public: 07630030807886
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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 Date: 09/06/2022
• Device Catalogue Number: 01.26.45.1150
• Device Lot Number: 172698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/29/2019
• 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: 63 YR
• Patient Weight: 77