MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 52

Model Number	01.26.45.0052
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 december 2019.Lot 140076: (b)(4) items manufactured and released on 25-mar-2014.Expiration date: 2019-02-28.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Other devices involved in the event: stem: quadra-h 01.12.23sn cementless, ha coated std stem # 3, short neck lot.135653 (k082792).Batch review performed on 06 december 2019.Lot 135653: (b)(4) items manufactured and released on 29-jan-2014.Expiration date: 2018-12-31.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.
Event or Problem Description
Revision surgery performed due to suspicion of infection 5 years 5 months and a half after primary.The implants were loose, especially the stem.
Additional Manufacturer Narrative
Clinical evaluation: late infection in cementless tha, 4.5 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.Other devices involved in the event.Implants from ceramtec 38.49.7188.545.20 ceramic liner ø 36 / e lot.7010888529.Manufacturer process review performed by the manufacturer.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 non-conformities regarding sterilization.As the ceramic parts are not available, no further investigation can be done.Implants from ceramtec 38.49.7179.285.00 biolox delta ceramic ball head 12/14 ø 36 size m 0 lot.7010888647.Manufacturer process review performed by the manufacturer.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 non-conformities regarding sterilization.As the ceramic parts are not available, no further investigation can be done.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 52
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9523300
• Report Number: 3005180920-2019-01085
• Device Sequence Number: 399422
• Product Code: LZO
• UDI-Device Identifier: 07630030807770
• UDI-Public: 07630030807770
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: 02/28/2019
• Device Model Number: 01.26.45.0052
• Device Catalogue Number: 01.26.45.0052
• Device Lot Number: 140076
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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: 63 YR