MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / E; HIP SHELL LINER

Model Number	01.26.3244HCT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was not possible to insert the versafitcup pe hc liner e 32mm in the versafitcup 52mm.The surgeon tried 2 liners and it was either not possible.Afterward, he implanted the 54mm versafit and with this cup, it was possible to insert the same liner.At least 30 minutes of delay occurred.
Additional Manufacturer Narrative
Batch review performed on 31 may 2022.Lot 2118276: (b)(4).Expiration date: 2026-dec-19.No anomalies found related to the problem.(b)(4).Additional devices involved batch review performed on 31 may 2022.Liner: versafitcup cc trio 01.26.3244hct flat pe hc liner ø 32 / e (k103352) lot 2118277: (b)(4).Expiration date: 2026-dec-19.No anomalies found related to the problem.(b)(4).Cup: versafitcup cc trio (b)(4) acetabular shell cc trio no-hole ø 52 (k122911) lot 2113088: (b)(4).Expiration date: 2026-nov-07.No anomalies found related to the problem.(b)(4).Visual inspection performed on 15 june 2022.The received parts were analysed, finding no evident particular signs.A functional test was performed in order to evaluate the copling between the shell and the liner; after few impactions, the liner was correctly inserted into the shell.From the received parts and information, it is not possible to determine the root cause of the event; a possible cause can be related to the presence of some residual of fluids in the bottom of the shell, preventing the total compling of the parts.

• Brand Name: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / E
• Common Device Name: HIP SHELL LINER
• 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: 14694831
• Report Number: 3005180920-2022-00470
• Device Sequence Number: 4744197
• Product Code: LZO
• UDI-Device Identifier: 07630030807572
• UDI-Public: 07630030807572
• 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: 2022
• 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): 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01.26.3244HCT
• Device Catalogue Number: 01.26.3244HCT
• Device Lot Number: 2118276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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: Other
• Patient Sex: Unknown