MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø36/E; HIP POLYETHYLENE HIGH-CROSS LINER

Catalog Number	01.32.3644HC10A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 july 2023: lot 1810850: (b)(4) items manufactured and released on 22-mar-2019.Expiration date: 2024-03-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other 2 similar reported events in the period of review.Additional involved implant: batch review performed on 03 july 2023 on ball heads: cocr 01.25.030 cocr ball head 12/14 ø 36 size s -3.5 (k080885) lot.2244748.Lot 2244748: (b)(4) items manufactured and released on 02-feb-2023.Expiration date: 2028-01-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event in the period of review.
Event or Problem Description
The patient had a primary hip surgery on (b)(6)2023.Immediately after the primary surgery, in post-op recovery on (b)(6)2023, the patient's head dislocated from the liner.The surgeon revised the liner and the surgery was completed successfully.Presently, on (b)(6)2023, the patient came in reporting pain due to a dislocation of the head from the liner.The surgeon revised the medacta cup and liner with competitor components and revised the medacta head with a medacta head.The surgery was completed successfully.

• Brand Name: LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø36/E
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17389616
• Report Number: 3005180920-2023-00543
• Device Sequence Number: 17112509
• Product Code: LPH
• UDI-Device Identifier: 07630040731034
• UDI-Public: 07630040731034
• 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: 2023
• Device Explanted Year: 2023
• 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): 07/25/2023

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 Expiration Date: 03/10/2024
• Device Catalogue Number: 01.32.3644HC10A
• Device Lot Number: 1810850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2019
• 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