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

Model Number	01.26.45.0050
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 october 2021: lot 178353: (b)(4) items manufactured and released on 20-mar-2018.Expiration date: 2023-mar-11.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Additional item involved in the event, batch review performed on 14 october 2021.Stem: quadra-h 01.12.22sn cementless, ha coated std stem size 2, short neck (k082792) lot.177574.Lot 177574: (b)(4) items manufactured and released on 03-apr-2018.Expiration date: 2023-mar-22.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director: 3 years after primary cementless tha dislocation is suspected and revision surgery undertaken.At surgery, the stem is well fixed and not replaced; the cup is exchanged and repositioned.It was verified that no dislocation occurred, rather impingement of the stem neck with the cup.This adverse event is due to component positioning and patient postural behaviour, not to a device defect.Visual inspection performed by r&d project manager: from the received pieces, evident signs of damage on a part of the rim of the liner and shell (still assembled together) were present: according to the received information, their clocking position in the shell and the x-ray pre-op image, their presence is most probably related to the point of impingement.In addition, a partial cut on a rim area of the liner was present, and some signs on the inner spherical socket were noticed: both these damages are probably related to the revision of the acetabular shell and liner.According to the received information and the x-ray images, a probable root cause of this event is related to a low inclination of the shell in its positioning inside the patient: the shell showed to be most horizontal respect to the recommended 40-45 degrees of inclination, and this could have caused the impingement on the rim of the shell-liner, as the damage position is close to the superior region of the shell, which is the rim with the higher risk of impingement, due to the fact that it is the closer to the stem and the one that protrudes from the bone.
Event or Problem Description
Revision surgery for due to impigment in abduction between the neck of the stem and the cup.At 3 years and 1 month after the primary surgery, cup, head, and liner were revised and the surgery was completed successfully.Cup was revised to improve the acetabular coverage and head was revised to extend the length of the leg.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50
• Common Device Name: VERSAFITCUP CC TRIO ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12786507
• Report Number: 3005180920-2021-00864
• Device Sequence Number: 17340499
• 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: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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: 03/11/2023
• Device Model Number: 01.26.45.0050
• Device Catalogue Number: 01.26.45.0050
• Device Lot Number: 178353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2018
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: White