MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR FEMORAL BALL HEAD; FEMORAL HEAD Ø 22 SIZE M

Model Number	01.25.123
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-oct-2024.Lot 2009346: (b)(4) items manufactured and released on 02-dec-2020.Expiration date: 2025-11-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Addiitonal devices involved, batch review performed on 11-oct-2024: liner: mpact dm 01.26.2246mhc double mobility hc liner 22.2/dmc (k092265) lot 2213368: (b)(4) items manufactured and released on 25-jul-2022.Expiration date: 2027-07-07.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported events during the period of review.Cup: mpact 01.32.146mb double mobility acetabular shell ø46 (k143453) lot 2238383: (b)(4) items manufactured and released on 06-sep-2024.Expiration date: 2028-08-16.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported events during the period of review.4 infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
At about 6 months after primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised successfully the cup, head and liner.

• Brand Name: COCR FEMORAL BALL HEAD
• Common Device Name: FEMORAL HEAD Ø 22 SIZE M
• 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: 20576414
• Report Number: 3005180920-2024-00897
• Device Sequence Number: 12804483
• Product Code: JDI
• UDI-Device Identifier: 07630030805479
• UDI-Public: 07630030805479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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 Expiration Date: 11/23/2025
• Device Model Number: 01.25.123
• Device Lot Number: 2009346
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2020
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 95 KG