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

Catalog Number	01.25.012
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At 2 months from the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised the medacta cocr, bipolar head and stem and revised the competitor cup and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 23 aug 2024 lot 2307377: (b)(4) items manufactured and released on 10-may-2023.Expiration date: 2028-04-22.No anomalies found related to the problem.To date, 52 items of the same lot have been sold with no similar reported event during the period of review.Additional components involved: batch review performed on 23 aug 2024.Ball heads: bipolar head 25060.2851 bipolar head ø28x51 (k091967) lot 2245354: (b)(4) items manufactured and released on 08-may-2023.Expiration date: 2028-04-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 27 aug 2024 stem: masterloc 01.39.411 cementless ti coated lat plus stem size 11 (k173267) lot 2304304: (b)(4) items manufactured and released on 06-jul-2023.Expiration date: 2028-06-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0
• Common Device Name: 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: 20157866
• Report Number: 3005180920-2024-00732
• Device Sequence Number: 4209565
• Product Code: JDI
• UDI-Device Identifier: 07630030805110
• UDI-Public: 07630030805110
• 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: 2024
• Device Explanted Year: 2024
• 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): 09/06/2024

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 Catalogue Number: 01.25.012
• Device Lot Number: 2307377
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2023
• 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: 87 YR
• Patient Sex: Male
• Patient Race: White