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

Catalog Number	01.32.146DH
Medical Device Problem Codes	Osseointegration Problem (3003); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2023-00872
• Device Sequence Number: 20710883
• Product Code: LPH
• UDI-Device Identifier: 07630030810701
• UDI-Public: 07630030810701
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 11/16/2023

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: 09/30/2018
• Device Catalogue Number: 01.32.146DH
• Device Lot Number: 132792
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2013
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White