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

Model Number	01.32.3241HCAT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 11 months after the primary, the patient came in reporting pain due to a dislocation of the head from the liner.The surgeon revised the hooded liner with a face changing liner and the surgery was completed successfully.An amis approach was used in the primary surgery.
Additional Manufacturer Narrative
Batch review performed on 12 december 2022 lot 2103119: (b)(4) items manufactured and released on 26-may-2021.Expiration date: 2026-05-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional item invovled in the event, batch review performed on 12 december 2022: ball heads: cocr 01.25.023 cocr ball head 12/14 ø 32 size l +3.5 (k072857) lot.2000364 lot 2000364: (b)(4) items manufactured and released on 28-may-2020.Expiration date: 2025-05-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: LINER: MPACT HOODED PE HC LINER Ø32/D
• Common Device Name: HOODED PE HC 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: 15987212
• Report Number: 3005180920-2022-00964
• Device Sequence Number: 12252634
• Product Code: LPH
• UDI-Device Identifier: 07630030811869
• UDI-Public: 07630030811869
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2022

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: 05/06/2026
• Device Model Number: 01.32.3241HCAT
• Device Catalogue Number: 01.32.3241HCAT
• Device Lot Number: 2103119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2021
• 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