MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 46/22.2; HIP ACETABULAR LINER

Catalog Number	01.26.2246MHC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Laxity (4526)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 june 2024 lot 134970: (b)(4) items manufactured and released on 13-jan-2014.Expiration date: 2018-11-30.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Other component involved in the event: cup: versafitcup 01.26.46mb acetabular shell ø 46 (k083116) lot 141659: (b)(4) items manufactured and released on 24-jun-2014.Expiration date: 2019-05-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation revision surgery almost 10 years after tha due to instability of the joint in a overweight patient.The first surgery was done when the patient was 60 year old.According to report, during revision a micro-fracture was found in the acetabulum and signs of pe wear were detected but in absence of explants no further analysis can be conducted.The clinical relevance of pe wear in this case is not described.From the radiographic image, the acetabulum seems quite medialized.We cannot tell if this is the result of post-surgery migration during these almost 10 years or the surgeon's choice: in the latter case, no explanation for this decision was supplied.
Event or Problem Description
Hip revision surgery at about 9 years and 10 months.The patient reported that the joint was not stable when riding a bike.During the revision, a micro-fracture was found in the acetabulum when the cup was removed and signs of wear on the poly were detected.No infection was detected.The surgeon revised the cup, liner, and head, to add offset and a bit of leg length to increase patient's stability.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 46/22.2
• Common Device Name: HIP ACETABULAR LINER
• 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: 19606526
• Report Number: 3005180920-2024-00478
• Device Sequence Number: 6334434
• Product Code: MEH
• UDI-Device Identifier: 07630030806834
• UDI-Public: 07630030806834
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• 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): 06/25/2024

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: 11/30/2018
• Device Catalogue Number: 01.26.2246MHC
• Device Lot Number: 134970
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2014
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 109 KG