MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø32/C; HIP POLYETHYLENE HIGH CROSS LINER

Model Number	01.32.3239HCT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for joint dislocation at about 1 month post pirmary.Ceramic head dislocated from the mpact 3d metal liner.
Additional Manufacturer Narrative
Batch review performed on 17january 2023: lot 2215494: 30 items manufactured and released on 02-sep-2022.Expiration date: 2027-08-02.No anomalies found related to the problem.To date, 14 items of the same lot have been sold without any similar reported event in the period of review.Additional involved implant: batch review performed on 17 january 2023 on ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot.2207380 lot 2207380: 200 items manufactured and released on 05-jul-2022.Expiration date: 2027-06-23.No anomalies found related to the problem.To date, 170 items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/C
• Common Device Name: HIP POLYETHYLENE 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16322506
• Report Number: 3005180920-2023-00037
• Device Sequence Number: 20997256
• Product Code: LPH
• UDI-Device Identifier: 07630030811845
• UDI-Public: 07630030811845
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 02/08/2023

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: 01.32.3239HCT
• Device Catalogue Number: 01.32.3239HCT
• Device Lot Number: 2215494
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2022
• 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