MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP 01.26.54MB ACETABULAR SHELL Ø 54

Model Number	01.26.54MB
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary hip surgery on (b)(6) 2013.On (b)(6) 2017, the patient came in reporting pain.The surgeon noticed that the patient had osteolysis and revised head and liner.Presently, the patient came in reporting pain due to a loose cup.The cause of the loose cup is unknown.The surgeon revised the cup, head, and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 02 march 2022.Lot 123781: (b)(4) items manufactured and released on 27-nov-2012.Expiration date: 2017-10-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2018.

• Brand Name: CUP: VERSAFITCUP 01.26.54MB ACETABULAR SHELL Ø 54
• Common Device Name: 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: 13949937
• Report Number: 3005180920-2022-00204
• Device Sequence Number: 6514428
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted 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): 03/30/2022

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: 10/31/2017
• Device Model Number: 01.26.54MB
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 123781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2012
• 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: 63 YR
• Patient Sex: Female