MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA DOUBLE MOBILITY LINER; VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø28/DMD

Model Number	01.26.2848MHC
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19-11-2024: lot 2405833: (b)(4) items manufactured and released on 13-08-2024.Expiration date: 2029-07-28.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 two days after the primary implantation of a total hip arthroplasty.The reported reason for the revision was a shifting of the acetabular cup, which caused the patient significant pain.The only available x-ray image is an intraoperative image from the primary surgery.It shows that the cup appears slightly lateralized, which may suggest improper impaction, possibly due to inadequate reaming of the acetabulum.The resulting lack of primary stability could have contributed to the early failure.However, this is only a possible explanation, and we lack the necessary information to draw definitive conclusions.
Event or Problem Description
2 days after the primary, the patient came in reporting pain of unknown cause, cup shifting has been hypothesized.The surgeon revised the cup, liner and head.The surgery was completed successfully.

• Brand Name: DOUBLE MOBILITY LINER
• Common Device Name: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø28/DMD
• 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: 20924286
• Report Number: 3005180920-2024-01023
• Device Sequence Number: 5043089
• Product Code: MEH
• UDI-Device Identifier: 07630030807244
• UDI-Public: 07630030807244
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/13/2024

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 Model Number: 01.26.2848MHC
• Device Lot Number: 2414819
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White