MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO 01.26.45.0052 ACETABULAR SHELL CC TRIO Ø 52; HIP ACETABULAR SHELL

Model Number	01.26.45.0052
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 april 2023: lot 113307: (b)(4) items manufactured and released on 16-nov-2011.Expiration date: 2016-oct-31.No anomalies found related to the problem.To date, 71 items of the same lot have been sold without any similar reported event in the period of review.Analysis performed by r&d manager: preliminary investigation performed on (b)(6) 2023.From the received images, the shell appear with the ha coating totally absorbed, which is absolutely common for a cup after more than 10 years; this indication should suggest a correct fixation of the shell in the human body.From the received images it is not possible to determine the root cause of the event, if caused by impingment between liner and neck/head or other causes.A further more detailed analysis can be performed with visual inspection.Other device involved: liner: versafitcup cc trio 01.26.3244hct flat pe liner ø 32 / e (k103352) lot 113342: (b)(4) items manufactured and released on 02-nov-2011.Expiration date: 2016-09-30.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
At about 11 years 2 months, revision surgery performed.The patient had osteolysis and the cup had loosened and moved.There was a sign of the head in the poly liner, like deformation/wear of the liner performed by the contact with the metal head.The surgeon revised successfully cup, liner and head.Stem was also removed.

• Brand Name: CUP: VERSAFITCUP CC TRIO 01.26.45.0052 ACETABULAR SHELL CC TRIO Ø 52
• Common Device Name: HIP ACETABULAR 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: 16963026
• Report Number: 3005180920-2023-00360
• Device Sequence Number: 5452717
• 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: 2012
• 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): 05/19/2023

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: 10/31/2016
• Device Model Number: 01.26.45.0052
• Device Catalogue Number: 01.26.45.0052
• Device Lot Number: 113307
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2011
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White