MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø32/D; FLAT PE LINER

Model Number	01.32.3241HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.At 3 years and 3 months from primary the surgeon revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 07 april 2022: lot 183923: (b)(4) items manufactured and released on 14-aug-2018.Expiration date: 2023-07-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event.Additional item involved in the event, batch review performed on 7 april 2022.Ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot.181294.Lot 181294: (b)(4) items manufactured and released on 18-jul-2018.Expiration date: 2023-07-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/D
• Common Device Name: FLAT PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 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: 14218338
• Report Number: 3005180920-2022-00300
• Device Sequence Number: 20173185
• Product Code: LPH
• UDI-Device Identifier: 07630030811876
• UDI-Public: 07630030811876
• 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: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2022

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: 07/22/2023
• Device Model Number: 01.32.3241HCT
• Device Catalogue Number: 01.32.3241HCT
• Device Lot Number: 183923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2018
• 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