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

Model Number	04.01.0207
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary hip surgery on (b)(6) 2021.At about 4 weeks after the primary, the patient came in reporting pain due to a periprosthetic fracture that was caused by falling.The surgeon plated the fracture and did not revise any implants.Presently, on (b)(6) 2022, the patient came in reporting pain.The surgeon re-plated the fracture and exchanged the head.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in reporting pain and the surgeon observed subluxation.The surgeon decided to revise the medacta head and sleeve to a new medacta head and sleeve and the medacta cup and liner to a competitor cup and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 10 february 2023.Lot 2011805: 55 items manufactured and released on 23-dec-2020.Expiration date: 2025-12-08.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 involved in the event, batch review performed on 10 february 2023: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115)lot.2007632 lot 2007632: 400 items manufactured and released on 25-nov-2020.Expiration date: 2025-11-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/E
• Common Device Name: HIP FLAT 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: 16501463
• Report Number: 3005180920-2023-00122
• Device Sequence Number: 14278381
• Product Code: LPH
• UDI-Device Identifier: 07630040728065
• UDI-Public: 07630040728065
• 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): 03/08/2023

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 Expiration Date: 12/08/2025
• Device Model Number: 04.01.0207
• Device Catalogue Number: 01.32.3244HCT
• Device Lot Number: 2011805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2020
• 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