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

Model Number	01.25.012
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed due to infection 2 years 2 months after the primary surgery.All implants were removed and revised.
Additional Manufacturer Narrative
Batch review performed on 01 march 2022.Lot 172860: (b)(4) items manufactured and released on 07-sep-2017.Expiration date: 2022-08-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2018.Additional components involved: stem: quadra-h 01.12.20sn cementless, ha coated std stem size 0, short neck (k082792) lot.189855: (b)(4) items manufactured and released on 12-feb-2019.Expiration date: 2024-01-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Liner: mpact 01.32.2837hct flat pe hc liner ø28/b (k103721) lot.176961: (b)(4) items manufactured and released on 01-march-2018.Expiration date: 2023-02-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Cup: mpact 01.32.146dh acetabular shell ø46 two-holes (k132879) lot.182585: (b)(4) items manufactured and released on 28-aug-2018.Expiration date: 2023-08-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0
• Common Device Name: HIP BALL HEAD COCR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13839894
• Report Number: 3005180920-2022-00198
• Device Sequence Number: 4655157
• Product Code: JDI
• UDI-Device Identifier: 07630030805110
• UDI-Public: 07630030805110
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 03/21/2022

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: 08/27/2022
• Device Model Number: 01.25.012
• Device Catalogue Number: 01.25.012
• Device Lot Number: 172860
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2022
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White