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

Model Number 01.25.031

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 26 may 2021: lot 2009343: (b)(4) items manufactured and released on 11-nov-2020.Expiration date: 2025-11-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

1 month after the primary surgery the patient came in reporting pain due to a dislocation of the head from the liner due to a length discrepancy.The cause of the leg length discrepancy is unknown.The surgeon revised the 36mm cocr head m with a 36mm cocr head xl.The surgery was completed successfully.

• Brand Name: COCR BALL HEAD 12/14 36 SIZE M 0
• Type of Device: HIP FEMORAL HEAD
• 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: 11946155
• MDR Text Key: 254789713
• Report Number: 3005180920-2021-00485
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030805219
• UDI-Public: 07630030805219
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• 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: 2009343
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2020
• 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