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

Model Number	01.32.158DH
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020.Lot 1905341: 69 items manufactured and released on (b)(6) 2019.Expiration date: 2024-08-21.No anomalies found related to the problem.To date, 20 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affaris manager during early revision surgery due to stem subsidence, 1 month after primay implantation, the acetabular component was also removed due to inappropriate position.Picture of the explants shows bone formation on the cup surface suggesting good osteointegration process.There is no reason to suspect a faulty device.Preliminary investigation performed by r&d project manager preliminary investigation performed on (b)(6) 2020.Revision surgery caused by a competitor's stem.From the received images we cannot determine anything regarding the root cause, but from the received information we can conclude that the event is not correlated to the acetabular shell.
Event or Problem Description
Revision surgery of competitor implants due to stem subsidence and fracture (unknown which is the main reason).Competitor stem has been revised on (b)(6) with anterior approach.During surgery, the femoral fracture was cabled and the stem revised and, while externally rotating and lowering the leg to prepare the femur, the gt fractured.The surgeon tried to repair the fracture but it was too posterior so he decided to cable the fracture the next day, (b)(6).Another surgery was then performed on march 19 (one month after primary surgery) using a posterior approach to repair the fracture.Cup and liner have been revised due to cup malpositioning.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9971098
• Report Number: 3005180920-2020-00244
• Device Sequence Number: 16858244
• Product Code: LPH
• UDI-Device Identifier: 07630030810893
• UDI-Public: 07630030810893
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2020

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: 08/21/2024
• Device Model Number: 01.32.158DH
• Device Catalogue Number: 01.32.158DH
• Device Lot Number: 1905341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 90