MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY SHELLS; HIP CEMENTLESS ACETABULAR SHELL DOUBLE MOBILITY

Model Number	01.26.48MB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Joint Impingement (4834)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had shell impingement with soft tissues and pain in the hip.At about 7 years and 7 months post primary the surgeon revised the cup, head and liner.The original cup was suspected to be too large and possibly leading to reduced range of motion.Medialized the new cup in an effort to alleviate impingement.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 08 october 2024.Lot 163138: (b)(4) items manufactured and released on 15-sep-2016.Expiration date: 2021-08-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY SHELLS
• Common Device Name: HIP CEMENTLESS ACETABULAR SHELL DOUBLE MOBILITY
• 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: 20512688
• Report Number: 3005180920-2024-00882
• Device Sequence Number: 8616248
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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: 08/29/2021
• Device Model Number: 01.26.48MB
• Device Lot Number: 163138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White