MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5; HIP FEMORAL HEAD

Model Number	01.25.021
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At 1 month from primary the surgeon performed a washout and revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 2108058: 120 items manufactured and released on (b)(6) 2021.Expiration date: 2026-09-06.No anomalies found related to the problem.To date, 106 items of the same lot have been sold without any similar reported event in the period of review.Additional component involved: liner: mpact 01.32.3241hcat hooded pe hc liner ø32/d (k132879) lot.2218086: 20 items manufactured and released on (b)(6) 2022.Expiration date: 2027-09-08.No anomalies found related to the problem.To date, 16 items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5
• Common Device Name: HIP FEMORAL 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: 16724726
• Report Number: 3005180920-2023-00281
• Device Sequence Number: 7950396
• Product Code: JDI
• UDI-Device Identifier: 07630030805158
• UDI-Public: 07630030805158
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2026
• Device Model Number: 01.25.021
• Device Catalogue Number: 01.25.021
• Device Lot Number: 2108058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2021
• 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
• Patient Sex: Female