MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 54; ACETABULAR CEMENTLESS SHELL

Catalog Number	01.26.45.1154
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: infection in cementless tha, 1.8 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.Batch review performed on 05 march 2019: lot 168186: (b)(4) items manufactured and released on 16-mar-2017.Expiration date: 2022-03-06.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.Additional components involved: stem: quadra-h 01.12.023 cementless, ha coated std stem size 3 (k082792), lot 170174: (b)(4) items manufactured and released on 05-may-2017.Expiration date: 2022-04-19.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.Liner: cc e cc light 01.26.3244hct flat pe hc liner ø 32 / e (k103352), lot 167566: (b)(4) items manufactured and released on 25-jan-2017.Expiration date: 2022-01-15.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.Batch review performed by the manufacturer ceramtec: the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There are no indications of any pre-existing material defect or nonconformities regarding sterilisation.Due to a lack of ceramic parts further investigations cannot be done.Preliminary investigation performed by r&d project manager: from the received images the versafitcup cc trio was just explanted from the patient, covered with blood and bone tissues and without any particular signs.It is not possible to determine the root cause of the event, but there is no reason to suspect that it may be linked to the implant.
Event or Problem Description
Revision surgery performed 1 year and 8 months after primary due to cup and stem loosening caused by infection, propionibacterium avidum.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 54
• Common Device Name: ACETABULAR CEMENTLESS SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8394838
• Report Number: 3005180920-2019-00126
• Device Sequence Number: 3057404
• Product Code: LZO
• UDI-Device Identifier: 07630030807909
• UDI-Public: 07630030807909
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/06/2019

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: 03/06/2022
• Device Catalogue Number: 01.26.45.1154
• Device Lot Number: 168186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 03/06/2019
• 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: 73 YR
• Patient Weight: 89