MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT OFFSET 4MM PE HC LINER Ø36/D; HIP ACETABULAR LINER

Model Number	01.32.3641HC4
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 december 2021: lot 1810834: (b)(4) items manufactured and released on 4-mar-2019.Expiration date: 2024-feb-20 no anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold wit 1 similar reported event.Additional components involved: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2011679.Lot 2011679: (b)(4) items manufactured and released on 23-feb-2021.Expiration date: 2026-feb-10 no anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported events.Cup: mpact 01.32.150dh acetabular shell ø50 two-holes (k132879) lot.1909289.Lot 1909289: (b)(4) items manufactured and released on 17-feb-2020.Expiration date: 2025-feb-02 no anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported events.
Event or Problem Description
At 5 months after the last surgery, the patient came in reporting pain due to a dislocation of the head from the liner and the cause of the dislocation is unknown.The surgeon revised the medacta cup and liner to a competitor component and revised the medacta head to a medacta head.The surgery was completed successfully.The surgeon revised the cup to change its position.The cup was malpositioned, so after repositioning the patient would not dislocate as easily now.This is the second revision surgery performed due to head-lined dislocation for this patient.

• Brand Name: LINER: MPACT OFFSET 4MM PE HC LINER Ø36/D
• Common Device Name: HIP ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13058895
• Report Number: 3005180920-2021-01029
• Device Sequence Number: 17121676
• Product Code: LPH
• UDI-Device Identifier: 07630040731010
• UDI-Public: 07630040731010
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 12/22/2021

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: 02/20/2024
• Device Model Number: 01.32.3641HC4
• Device Catalogue Number: 01.32.3641HC4
• Device Lot Number: 1810834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2019
• 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: Female