MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0; HIP BALL HEAD

Model Number	01.25.012
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in reporting pain due to a periprosthetic fracture and the cause is unknown.The surgeon cabled the fracture and revised successfully the stem, head, and liner.On (b)(6) 2022, the patient came in reporting pain due to developing a hematoma and the cause is unknown.The surgeon revised the head and liner.Presently, on (b)(6) 2023, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon revised the medacta stem and head with a new medacta stem and head and revised the medacta cup and liner with a competitor cup and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 13-apr-2023: lot 2109389: (b)(4) items manufactured and released on 13-oct-2021.Expiration date: 2026-10-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Other devices involved: liner: versafitcup dm 01.26.2852mhc double mobility hc liner ø 52/28 (k092265) lot 2116153: (b)(4) items manufactured and released on 12-jan-2022.Expiration date: 2026-12-15.No anomalies found related to the problem.To date, 159 items of the same lot have been sold with no similar reported case during the period of review.Stem: m-vizion 01.22.009 proximal body ø20mm l 60mm lat (k170690) lot 186407: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 2024-11-23.No anomalies found related to the problem.To date, 11 items of the same lot have been sold with no similar reported case during the period of review.Stem: m-vizion 01.22.106 distal stem ø17mm l 140mm straight (k170690) lot 2006791: (b)(4) items manufactured and released on 26-oct-2020.Expiration date: 2025-10-15.No anomalies found related to the problem.To date, 14 items of the same lot have been sold with no similar reported case during the period of review.Cup: mpact 01.32.152mb double mobility acetabular shell ø52 (k143453) lot 2105720: (b)(4) items manufactured and released on 26-oct-2021.Expiration date: 2026-10-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0
• Common Device Name: HIP BALL HEAD
• 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: 16741312
• Report Number: 3005180920-2023-00268
• Device Sequence Number: 6446059
• Product Code: JDI
• UDI-Device Identifier: 07630030805110
• UDI-Public: 07630030805110
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/14/2023

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: 10/04/2026
• Device Model Number: 01.25.012
• Device Catalogue Number: 01.25.012
• Device Lot Number: 2109389
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2021
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 127 KG