MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø46 TWO-HOLES; HIP ACETABULAR SHELL

Catalog Number 01.32.146DH

Device Problems Osseointegration Problem (3003); Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/17/2023

Event Type  Injury  

Event Description

Revision surgery due to cup loosening, at about 7 years 7 months from the primary.The surgeon revised successfully cup, liner and head.The patient experienced pain and subluxing feeling of the right hip since the primary surgery in 2016.Episodes of joint luxation not confirmed.The surgeon reported signs of the stem impingement on the cup in end of range hip flexion.

Manufacturer Narrative

Batch review performed on 20 october 2023.Lot 132792: (b)(4) items manufactured and released on 11-dec-2013.Expiration date: 2018-09-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision surgery 7 years and 7 months after the primary tha, due to cup loosening in a 52 year old female patient.According to report, the patient experienced pain and "subluxing" feeling of the operated hip since the initial surgery in 2016.From the radiographic image, the position of the cup seems to be suboptimal.We cannot tell if this is the result of the cup loosening, leading to a post-surgery migration, or the surgeon's choice.In the latter case, no explanation for this decision was supplied.In these conditions, it may be possible that part of the femoral stem may impinge with the cup, as the surgeon reported.There is no reason to suspect a faulty device.Preliminary analysis performed by r&d project manager: from the received images it is difficult to determine the causes, even if it seems that an enhanced anteversion was provided to the cup that could have potentially an increased impingement with the femoral component.However, from the received information and images, it was not possible to determine the root cause of the event.Additional implant involved: batch review performed on 20 october 2023 on stem: quadra-h 01.12.20sn cementless, ha coated std stem size 0, short neck (k082792) lot.147643.Lot 147643: (b)(4) items manufactured and released on 19-jan-2015.Expiration date: 2019-12-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø46 TWO-HOLES
• Type of Device: HIP ACETABULAR SHELL
• 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: 18146682
• MDR Text Key: 328224590
• Report Number: 3005180920-2023-00872
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030810701
• UDI-Public: 07630030810701
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132879
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 01.32.146DH
• Device Lot Number: 132792
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2013
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White