MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø40/G; HIP SHELL LINER

Model Number	01.32.4052HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 march 2022: lot 165678: (b)(4).Expiration date: 2021-10-06.No anomalies found related to the problem.To date, (b)(4).Additional device involved batch review performed on 21 march 2022: ball heads: mectacer 01.29.215 biolox delta ceramic ball head 12/14 ø 40 size xl +8 (k112115) lot 141175: (b)(4).Expiration date: 2019-04-30.No anomalies found related to the problem.To date, (b)(4).
Event or Problem Description
Revision surgery performed 3 years 11 months after the primary due to hip luxation (liner from head).The surgeon revised the medacta liner with a competitor constrained liner and revised the medacta head to a medacta head.

• Brand Name: MPACT FLAT PE HC LINER Ø40/G
• Common Device Name: HIP SHELL 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: 14072432
• Report Number: 3005180920-2022-00251
• Device Sequence Number: 11412032
• Product Code: LZO
• UDI-Device Identifier: 07630030812286
• UDI-Public: 07630030812286
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• 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): 04/11/2022

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: 10/06/2021
• Device Model Number: 01.32.4052HCT
• Device Catalogue Number: 01.32.4052HCT
• Device Lot Number: 165678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2016
• 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: Male