MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DM DM CONVERTER TIN COATED D/DMB; HIP DM CONVERTER TIN COATED

Catalog Number	01.32.3641CF
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary with mpact no hole cup, mpact dm converter and double mobility liner implanted on the (b)(6) 2024.The cup was placed as usual, 40 inclination and roughly 20 anteversion.The patient showed signs of a spinal deformity.The patient dislocated posteriorly 3 times over in 2 weeks.It was found that the patient had an extremely hyper mobile hip (extremely lax in her ligaments) and her hip posterior capsule was detached.The surgeon decided to remove the mpact no hole cup with dm converter liner, the double mobility liner and put in a highly constrained cup (of competitor).This was done on the (b)(6) 2024.The surgeon reported that he does not believe this was an implant fault, the patient just required a more constraint hip configuration.
Additional Manufacturer Narrative
Batch review performed on 03 june 2024 lot 2302176: (b)(4) items manufactured and released on 12-jul-2023.Expiration date: 2028-06-24.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.Additional components involved in the event: liner: mpact dm 01.26.2244mhc double mobility hc liner 22.2/dmb (k131458) lot 2314368: (b)(4) items manufactured and released on 28-sep-2023.Expiration date: 2028-09-12.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.

• Brand Name: LINER: MPACT DM DM CONVERTER TIN COATED D/DMB
• Common Device Name: HIP DM CONVERTER TIN COATED
• 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: 19623329
• Report Number: 3005180920-2024-00440
• Device Sequence Number: 6520480
• Product Code: LZO
• UDI-Device Identifier: 07630971256347
• UDI-Public: 07630971256347
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K211891
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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: 01.32.3641CF
• Device Lot Number: 2302176
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2023
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White