MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY SHELLS; VERSAFITCUP METALBACK DM Ø52 MM

Model Number	01.26.52MB
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation 10 years after primary cementless dm tha, the cup gets loose and it is replaced.The primary surgery was executed with a rather low resection at femoral level, which probably required the use of the xxl head.In spite of this, the replacement apparently served well for ten years.The secondary mobilization of the cup, in absence of trauma, is a rare occurrence and we do not have any clue that can lead us towards understanding the reasons.We would therefore have no choice but recording this event as idiopathic aseptic loosening.Batch review performed on 27 april 2026 lot: 154801: (b)(4) items manufactured and released on 25-nov-2015.Expiration date: 2020-nov-11.No anomalies found related to the problem.To date, all items of the same lot have been sold with one similar reported event during the period of review.Root cause: aseptic loosening is a possible literature-described adverse event following primary hip arthroplasty, and its causes are often multifactorial or remain unknown.In this specific case, the secondary mobilization of the cup occurred in the absence of any reported trauma and represents a rare occurrence for which no definitive contributing factor could be identified.The investigation performed, including the device history record review, did not reveal any indication of manufacturing-related nonconformities or any potential issue with the device that may have caused or contributed to the event.Therefore, based on the available information, the event is considered consistent with an idiopathic aseptic loosening.
Event or Problem Description
Revision due to cup loosening after about 10 years and 2 months from primary.There were no indications of trauma.The surgeon revised the medacta cup and liner to a competitor cup and liner and revised the medacta 28mm cocr head xxl to a d 28 biolox option head with sleeve.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY SHELLS
• Common Device Name: VERSAFITCUP METALBACK DM Ø52 MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25148967
• Report Number: 3005180920-2026-00416
• Device Sequence Number: 16140310
• Product Code: MEH
• UDI-Device Identifier: 07630030808098
• UDI-Public: 07630030808098
• Combination Product (Y/N): N
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 11/11/2020
• Device Model Number: 01.26.52MB
• Device Lot Number: 154801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2015
• 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: 64 YR
• Patient Sex: Male