MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY SHELLS; VERSAFITCUP METALBACK DM Ø48 MM

Model Number	01.26.48MB
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/19/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-july-2025: lot.091607: (b)(4) items manufactured and released on 21-aug-2009.Expiration date: 2014-06-30.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.Clinical evaluation performed by medacta medical affairs manager: a revision surgery was performed 15 years after the primary total hip arthroplasty implantation due to loosening of the cup.The reported reason for the loosening was "long term wear".Radiographic examination reveals signs consistent with mobilization of the acetabular cup, notably areas of reduced bone density within the acetabulum that may represent osteolysis related to pe particle release.On the stem side, small radiolucent areas are present proximally; however, these did not compromise implant stability, and consequently the stem was not revised.A particle release (possibly associated to long term wear) from a standard pe dual-mobility liner after 15 years aligns with common findings reported extensively in medical literature.We do not find this event indicative of a faulty product.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At about 15 years and 4 months from primary, the patient came in reporting pain due to a loose cup.The cause of the loose cup and instability is unknown.The surgeon revised the cup, head and liner.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY SHELLS
• Common Device Name: VERSAFITCUP METALBACK DM Ø48 MM
• 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: 22554190
• Report Number: 3005180920-2025-00686
• Device Sequence Number: 9559440
• 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: 2010
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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: 06/30/2014
• Device Model Number: 01.26.48MB
• Device Lot Number: 091607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 70 YR
• Patient Sex: Female
• Patient Race: White