MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 01.32.158DH ACETABULAR SHELL Ø58 TWO-HOLES; HIP ACETABULAR SHELL

Catalog Number 01.32.158DH

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/29/2024

Event Type  Injury  

Event Description

At 4 years and 3 months from the primary, revision surgery due to leg length discrepancy.There was <1mm lld, but the patient was unhappy.Therefore, the surgeon decided to revise the cup to change the offset and leg length marginally.Cup, liner and femoral head components were removed and replaced with competitor's components.

Manufacturer Narrative

Batch review performed on (b)(6) 2024.Lot 1900184: (b)(4) items manufactured and released on 08-may-2019.Expiration date: 2024-04-24.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.Other devices involved: liner: mpact 01.32.3648hcat hooded pe hc liner ø36/f (k132879) lot 176974: (b)(4) items manufactured and released on 01-march-2018.Expiration date: 2023-02-14.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 1903857: (b)(4) items manufactured and released on 31-jul-2019.Expiration date: 2024-07-16.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.Screws: mpact 01.32.6520 cancellous bone screw, flat head ø 6,5 l 20 (k103721) lot 1904926: (b)(4) items manufactured and released on 17-jul-2019.Expiration date: 2024-06-29.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.Analysis performed by r&d project manager.From the received images no particular signs were noticed: the components, in particular the polyethylene liner, were slightly damaged for the removal.From the received images and information, we cannot determine the root cause of the event, but the leg length discrepancy was probably related to the positioning of the implants.Clinical evaluation performed by medical affair director a revision of the acetabular components was performed 4 years and 3 months after the primary tha.According to report, the reason of the revision was leg length discrepancy (lld).From the available x-rays the lld can be confirmed by comparing the two sides, as well as an increased lateral offset: this may have caused functional discomfort to the patient.There are no signs of loosening or infection on either the acetabular or femoral side.There is no reason to suspect a defective or malfunctioning device.

• Brand Name: CUP: MPACT 01.32.158DH ACETABULAR SHELL Ø58 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: 18991056
• MDR Text Key: 338880720
• Report Number: 3005180920-2024-00149
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030810893
• UDI-Public: 07630030810893
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.32.158DH
• Device Lot Number: 1900184
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2019
• 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