MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48; HIP AETABULAR SHELL

Model Number	01.26.45.0048
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
All right hip components revised about 8 years and 10 months after the primary surgery, due to loosening of the femoral stem, likely caused by an infection.
Additional Manufacturer Narrative
Batch review performed on 31-mar-2023.Lot 133037: (b)(4) items manufactured and released on 13-sep-2013.Expiration date: 2018-08-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department: revision 8 years and 10 months after primary operation, due to stem loosening.According to report the reason may be a late infection.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 items involved in the event, batch review performed on 31-mar-2023: liner: versafitcup cc trio 01.26.3239hct flat pe hc liner ø 32 / c (k120531) lot.136289 lot 136289: (b)(4) items manufactured and released on 10-feb-2014.Expiration date: 2018-12-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Ball heads: cocr 01.25.021 cocr ball head 12/14 ø 32 size s -3.5 (k072857) lot.124254 lot 124254: (b)(4) items manufactured and released on 04-dec-2012.Expiration date: 2017-10-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Stem: quadra-h 01.12.20sn cementless, ha coated std stem size 0, short neck (k082792) lot.132362 lot 132362: (b)(4) items manufactured and released on 22-jul-2013.Expiration date: 2018-06-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48
• Common Device Name: HIP AETABULAR SHELL
• 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: 16761590
• Report Number: 3005180920-2023-00273
• Device Sequence Number: 19598933
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• 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: 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): 04/18/2023

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: 08/31/2018
• Device Model Number: 01.26.45.0048
• Device Catalogue Number: 01.26.45.0048
• Device Lot Number: 133037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2013
• 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 Age: 80 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White