MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT 01.26.2844HCT FLAT PE HC LINER 28 / E; HIP LINER FLAT

Model Number	01.26.2844HCT
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20.07.2021.Lot 181142: (b)(4) items manufactured and released on 29-may-2018.Expiration date: 2023-05-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event.Other device involved: batch review performed on 20.07.2021.Ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.1901932: (b)(4) items manufactured and released on 17-jun-2019.Expiration date: 2024-05-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event.
Event or Problem Description
Revision surgery planned 1 year and 5 months after the primary due to dislocation.Liner and head has been revised.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs manager on 14 september 2021: hip dislocation 1 year and 5 months after primary implantation.Hip dislocation may be due to component positioning or insufficient soft tissue tensioning; it can hardly be caused by standard devices.

• Brand Name: LINER: CC E CC LIGHT 01.26.2844HCT FLAT PE HC LINER 28 / E
• Common Device Name: HIP LINER FLAT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12267572
• Report Number: 3005180920-2021-00651
• Device Sequence Number: 14413419
• Product Code: LZO
• UDI-Device Identifier: 07630030807176
• UDI-Public: 07630030807176
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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: 05/14/2023
• Device Model Number: 01.26.2844HCT
• Device Catalogue Number: 01.26.2844HCT
• Device Lot Number: 181142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 52