MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 62; UNCEMETED HIP SHELL

Catalog Number	01.26.45.0062
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019; lot 176990: (b)(4) items manufactured and released on (b)(6) 2018.Expiration date: 2023-02-07.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.Clinical evaluation performed by medacta medical affairs director delayed infection in cementless tha, 11 months 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.Additional devices involved: batch reviews performed on (b)(6) 2019: quadra-h 01.12.028 cementless, (b)(6) (k082792) lot 041380/t: (b)(4) items manufactured and released on (b)(6) 2015.Expiration date: 2020-01-31.No anomalies found related to the problem.To date, (b)(4) of the same lot have been already sold.Mectacer 01.29.208 biolox delta ceramic ball head 12/14 (b)(6) (k112115) lot 180538: (b)(4) items manufactured and released on (b)(6) 2018.Expiration date: 2023-06-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.
Event or Problem Description
Patient had an infected hip.We were informed on the (b)(6) 2019 of the revision surgery planned and performed on the (b)(6) 2019, 11 months after primary.All components have been removed.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 62
• Common Device Name: UNCEMETED HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9075828
• Report Number: 3005180920-2019-00778
• Device Sequence Number: 11382083
• Product Code: LZO
• UDI-Device Identifier: 07630030807824
• UDI-Public: 07630030807824
• 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: 2018
• 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): 09/17/2019

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: 02/07/2023
• Device Catalogue Number: 01.26.45.0062
• Device Lot Number: 176990
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/17/2019
• 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: 58 YR
• Patient Weight: 110