MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA DOUBLE MOBILITY LINER; HIP ACETABULAR LINER

Model Number	01.26.2852M
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 september 2024 liner: (b)(4) dm 01.26.2852m double mobility liner ø 52/28 lot 091604: (b)(4) items manufactured and released on 12-sep-2009.Expiration date: 2014-07-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional component involved: ball heads: mectacer 38.39.7175.255.00 biolox forte ceramic ball head 12/14 ø 28 size m 0 (usa) (k073337) lot 092211: (b)(6) items manufactured and released on 10-sep-2009.Expiration date: 2014-08-31.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
Revision surgery due to suspected pe hc liner and ceramic head wear, at about 14 years 10 months.The surgeon revised the head and liner.The surgery was completed successfully.

• Brand Name: DOUBLE MOBILITY LINER
• Common Device Name: HIP ACETABULAR 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: 20448874
• Report Number: 3005180920-2024-00817
• Device Sequence Number: 8532450
• Product Code: MEH
• UDI-Device Identifier: 07630030807336
• UDI-Public: 07630030807336
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2024

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: 07/31/2014
• Device Model Number: 01.26.2852M
• Device Lot Number: 091604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2009
• 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 Sex: Unknown