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

Model Number	01.32.3644HC4
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 april 2022.Lot 2011818: (b)(4) items manufactured and released on 05-feb-2021.Expiration date: 2026-jan-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional implant involved: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.2108575.Batch review performed on 27 april 2022.Lot 2108575: (b)(4) items manufactured and released on 30-sep-2021.Expiration date: 2026-sep-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
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.About 2 months and a half after the primary surgery, the surgeon revised the head and liner and the surgery was completed successfully.

• Brand Name: LINER: MPACT OFFSET 4MM PE HC LINER Ø36/E
• Common Device Name: ACETABULAR PE HC 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: 14485253
• Report Number: 3005180920-2022-00392
• Device Sequence Number: 12096273
• Product Code: LPH
• UDI-Device Identifier: 07630040731058
• UDI-Public: 07630040731058
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183582
• 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): 05/24/2022

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: 01/21/2026
• Device Model Number: 01.32.3644HC4
• Device Catalogue Number: 01.32.3644HC4
• Device Lot Number: 2011818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2021
• 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