MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50; HIP ACETABULAR CUP

Model Number	01.26.45.0050
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 march 2023.Lot: 124691: (b)(4) items manufactured and released on 19-dec-2012.Expiration date: 2017-nov-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event.Additional components involved: liner: versafitcup cc trio 01.26.3244stt flat pe liner ø 32 / e (k103352) lot: 124719: (b)(4) items manufactured and released on 14-jan-2013.Expiration date: 2017-nov-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event.Ball heads: cocr 01.25.022 cocr ball head 12/14 ø 32 size m 0 (k072857) lot: 131737: (b)(4) items manufactured and released on 24-jun-2013.Expiration date: 2018-may-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event.Visual inspection performed by r&d project manager.From the analysis of the received components, it is possible to note the presence of bone tissue in the macrostructures of the shell.No other notable signs are visible.In the liner, inner surface wear can be noted, which is acceptable after almost 10 years from the primary surgery, considering also it is standard pe (uhmwpe).Moreover, some signs of damage are present on the liner rim due to the removal.Based on the information available, it is not possible to determine the root cause of the event.
Event or Problem Description
Revision performed 9 years and 5 months after the primary surgery due to cup loosening.It has been reported that, during the revision, signs of wear were detected on the liner.Head, liner and cup revised successfully.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50
• Common Device Name: HIP ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16591724
• Report Number: 3005180920-2023-00174
• Device Sequence Number: 4947617
• Product Code: LZO
• UDI-Device Identifier: 07630030807763
• UDI-Public: 07630030807763
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

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: 11/30/2017
• Device Model Number: 01.26.45.0050
• Device Catalogue Number: 01.26.45.0050
• Device Lot Number: 124691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown