MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY HC LINER 28/DME; HIP DOUBLE MOBILITY LINER

Catalog Number	01.26.2850MHC
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At 2 years and 1 month from the primary, revision due to reduced leg length and related luxation risk.Inlay change and elongation with competitor's head.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 1900247: (b)(4) manufactured and released on 17-apr-2019.Expiration date: 2024-04-07.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Additional device involved: ball heads: cocr 01.25.013 cocr ball head 12/14 ø 28 size l +3.5 (k072857) batch review performed on (b)(6) 2023.Lot 1810702: (b)(4) manufactured and released on 12-mar-2019.Expiration date: 2024-03-02.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: revision 2 years and 1 month after the primary tha, due to reduced leg length and risk of luxation.In what looks like a cemented stem, it is extremely rare to have subsidence if the correct technique has been followed.This event caused a significant shortening and the surgeon decided to not remove the stem but to lengthen the stem with a competitor's head.Surely there were medical reason to do so, however, this condition, which is off-label, on such a heavy patient increase the risk of device failure.

• Brand Name: MPACT DOUBLE MOBILITY HC LINER 28/DME
• Common Device Name: HIP DOUBLE MOBILITY 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: 17718219
• Report Number: 3005180920-2023-00705
• Device Sequence Number: 12585086
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/11/2023

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: 04/07/2024
• Device Catalogue Number: 01.26.2850MHC
• Device Lot Number: 1900247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2019
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White