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

Catalog Number 01.26.2850MHC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/17/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 323038035
• Report Number: 3005180920-2023-00705
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K092265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2024
• Device Catalogue Number: 01.26.2850MHC
• Device Lot Number: 1900247
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White