MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL

Catalog Number	01.32.148MB
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 march 2019: lot 184743: (b)(4) items manufactured and released on 05-nov-2018.Expiration date: 2023-10-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager: immediate postoperative acetabular fracture after total hip replacement in a 78 year old woman.Intraoperative bone weakening due to normal acetabular preparation in association with poor bone quality are conditions that may favour the occurrence of early fractures.In this case, there is no reason to suspect a malfunctioning device.
Event or Problem Description
Acetabulum bone fracture discovered with post-operative x-rays (osteoporotic patient) the same day of the primary.Conservative treatment with partial weight bearing has been done and is doing well.No revision surgery is planned at this time.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8460364
• Report Number: 3005180920-2019-00206
• Device Sequence Number: 19564801
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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: 10/22/2023
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 184743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/28/2019
• 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: Other
• Patient Age: 78 YR
• Patient Weight: 80