MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 36 SIZE M 0; HIP COCR BALL HEAD

Model Number	01.25.031
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 february 2023: lot 161630c: (b)(4) items manufactured and released on 18-may-2021.Expiration date: 2026-05-03.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Lot 161630: (b)(4) items manufactured and released on 11-may-2016.Expiration date: 2021-04-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional device involved.Batch review performed on 23 february 2023: liner: mpact 01.32.3644hcat hooded pe hc liner ø36/e (k132879) lot 2202312: (b)(4) items manufactured and released on 03-march-2022.Expiration date: 2027-02-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
Revision surgery performed at about 8 months after primary due to joint luxation (head from liner).The surgeon revised successfully the head and liner.

• Brand Name: COCR BALL HEAD 12/14 Ø 36 SIZE M 0
• Common Device Name: HIP COCR 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16529554
• Report Number: 3005180920-2023-00062
• Device Sequence Number: 19472165
• Product Code: JDI
• UDI-Device Identifier: 07630030805219
• UDI-Public: 07630030805219
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080885
• 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): 03/13/2023

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: 05/03/2026
• Device Model Number: 01.25.031
• Device Catalogue Number: 01.25.031
• Device Lot Number: 161630C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2021
• 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: 81 YR
• Patient Sex: Male