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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/16/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 311212340
• Report Number: 3005180920-2023-00062
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030805219
• UDI-Public: 07630030805219
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K080885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 01.25.031
• Device Catalogue Number: 01.25.031
• Device Lot Number: 161630C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male