MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA DOUBLE MOBILITY LINER; HIP DOUBLE MOBILITY LINER PE HIGH CROSS LINER

Model Number	01.26.2246MHC
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13-dec-2024: lot 2302829: (b)(4) items manufactured and released on 13-04-2023.Expiration date: 2028-03-23.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.Preliminary anaylsis performed by r&d project manager: looking the received photo, the liner still has the femoral ball head engaged inside and appears without any particular signs or defect.From the received information and image, it is not possible to determine the root cause of the event.Additional implant involved: batch review performed on 13-dec-2024 on ball heads: cocr 01.25.123 cocr ball head 12/14 ø 22 size m 0 (k080885) lot.2405012.Lot 2405012: (b)(4) items manufactured and released on 10-06-2024.Expiration date: 2029-05-26.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.Infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
Almost one month after primary the patient developed an infection.A washout was performed and liner and head were revisioned.Surgery was completed successfully.

• Brand Name: DOUBLE MOBILITY LINER
• Common Device Name: HIP DOUBLE MOBILITY LINER PE HIGH CROSS 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: 21026659
• Report Number: 3005180920-2024-01110
• Device Sequence Number: 9022811
• Product Code: MEH
• UDI-Device Identifier: 07630030806834
• UDI-Public: 07630030806834
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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: 01.26.2246MHC
• Device Lot Number: 2302829
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2023
• 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: 59 YR
• Patient Sex: Female