MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø36/E; HIP LINER

Catalog Number	01.32.3644HCT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2023.On (b)(6) 2024 the patient came in reporting pain due to a dislocation of the head from the liner.The surgeon revised successfully the head and liner.On (b)(6) 2024, the patient came in reporting pain due to joint luxation and the cause is unknown.The cup was malpositioned in the primary surgery and probably this caused the dislocation.The surgeon revised the head, cup and liner and implanted a double mobility cup and liner and ball head.The surgery was completed successfully.Patient bone quality was excellent.
Additional Manufacturer Narrative
Batch review performed on 28-may-2024.Lot 2317569: (b)(4) items manufactured and released on 24-aug-2023.Expiration date: 2028-08-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Additional devices involved: batch reviews performed on 28-may-2024: cup: mpact 3d metal 01.38.052dh acetabular shell 52 two-hole (k171966) lot 2335545: (b)(4) items manufactured and released on 27-sep-2023.Expiration date: 2028-09-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot 2336694: 195 items manufactured and released on 13-oct-2023.Expiration date: 2028-09-18.No anomalies found related to the problem.To date, 187 items of the same lot have been sold with another similar reported event during the period of review.Investigation performed by medacta hip r&d project manager: the images show the cup just explanted, with blood and bone tissue on its surface, no other details are evidenced.From the received images and information it is not possible to determine any root cause of the event.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø36/E
• Common Device Name: HIP 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: 19566894
• Report Number: 3005180920-2024-00430
• Device Sequence Number: 20625006
• Product Code: LPH
• UDI-Device Identifier: 07630030812118
• UDI-Public: 07630030812118
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 06/19/2024

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 Catalogue Number: 01.32.3644HCT
• Device Lot Number: 2317569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2023
• 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