MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO VERSAFITCUP METALBACK CC TRIO NO-HOLE 54; CEMENTLESS ACETABULAR PROSTHESIS

Model Number	01.26.45.1154
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 august 2021: lot 152059: (b)(4) items manufactured and released on 12-june-2015.Expiration date: 2020-04-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event since 2017.Clinical evaluation performed by medical affairs manager: acetabular component revision surgery performed 5 years and 9 months after cementless total hip arthroplasty in a (b)(6) year old man.No information concerning patient's general health status and presence of comorbidities is available.Radiographic images provided show the presence of cup migration.The original position of the cup cannot be assessed not having immediate postoperative images.No conclusion can be drawn on the basis of evidence collected.
Event or Problem Description
5 years and 9 months after the primary surgery the patient came in due to a loose cup and the cause of the loose cup is unknown.The surgeon revised the cup and liner.

• Brand Name: CUP: VERSAFITCUP CC TRIO VERSAFITCUP METALBACK CC TRIO NO-HOLE 54
• Common Device Name: CEMENTLESS ACETABULAR PROSTHESIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12473172
• Report Number: 3005180920-2021-00742
• Device Sequence Number: 3779692
• Product Code: LZO
• UDI-Device Identifier: 07630030807909
• UDI-Public: 07630030807909
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 09/15/2021

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: 04/30/2020
• Device Model Number: 01.26.45.1154
• Device Catalogue Number: 01.26.45.1154
• Device Lot Number: 152059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 90