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

Model Number	01.26.54MB
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 may 2023.Lot 110823: (b)(4) items manufactured and released on 27-may-2011.Expiration date: 2016-04-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation: on (b)(6) 2023, 5 years and 7 months after revision tha surgery, the patient came in reporting pain.From the radiographic image, the position of the acetabular cup appears to be suboptimal.We cannot tell if this is the result of post-surgery migration or the surgeon's choice: in the latter case, no explanation for this decision was supplied.There is no reason to suspect a malfunctioning device.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2011 on (b)(6) 2017, the patient came in complaining of a leg length discrepancy.The surgeon revised the head and liner.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in reporting pain due to loosened cup and the cause is unknown.The surgeon revised the medacta cup and liner with competitor components and revised the medacta head with a medacta head.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP 01.26.54MB ACETABULAR SHELL Ø 54
• Common Device Name: HIP ACETABULAR CUP
• 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: 17142662
• Report Number: 3005180920-2023-00425
• Device Sequence Number: 16618123
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 06/15/2023

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: 04/30/2016
• Device Model Number: 01.26.54MB
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 110823
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2011
• 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 Sex: Male