MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 54/28; HIP DOUBLE MOBILITY LINER

Catalog Number	01.26.2854M
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 april 2024: lot 090086: (b)(4) items manufactured and released on 06-apr-2009.Expiration date: 2014-feb-28.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional device involved: batch review performed on 10 april 2024: stem: quadra-s 01.12.005 cementless, sand blasted std stem size 5 (k072857) lot 080987: (b)(4)items manufactured and released on 23-jun-2008.Expiration date: 2013-apr-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 clinical affairs department: revision surgery 14 years and 10 months after the primary tha in a 77 year old patient due to osteolysis in the proximal femur.A standard polyethylene dual mobility liner had been implanted and after more than 14 years osteolysis may be the consequence of polyethylene wear that is commonly seen and described in literature.Pictures analysis performed by r&d project manager: from the received photos and information a sign on the external surface is present on the dm liner.We do not have the certainty of the root cause of the event, but a possible reason can be related to the presence of a third body.
Event or Problem Description
Revision surgery due to pain about 14 years and 10 months after the primary surgery.Signs of osteolysis were noted around the proximal femur.It is unknown if the liner was worn.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 54/28
• Common Device Name: HIP DOUBLE MOBILITY 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: 19249217
• Report Number: 3005180920-2024-00283
• Device Sequence Number: 7244142
• Product Code: MEH
• UDI-Device Identifier: 07630030807374
• UDI-Public: 07630030807374
• 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: 2009
• Device Explanted Year: 2024
• 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): 05/06/2024

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: 02/28/2014
• Device Catalogue Number: 01.26.2854M
• Device Lot Number: 090086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2009
• 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: 76 YR
• Patient Sex: Male