MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 32 SIZE S -3.5

Model Number	01.25.021
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 december 2020: lot 2001940: (b)(4) items manufactured and released on 01-jul-2020.Expiration date: 2025-06-18.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.Clinical evaluation performed by medacta medical affairs department: one month after primary cementless tha dislocation occurs and the head is exchanged to a longer one.No device malfunction, the root cause is most probably insufficient soft tissue tension and relaxation secondary to surgery and rehabilitation.Additional device involved: batch review performed on 21 december 2020: liner: cc e cc light 01.26.3239hct flat pe hc liner ø 32 / c (k120531)lot.2006350.Lot 2006350: (b)(4) items manufactured and released on 16-jul-2020.Expiration date: 2025-07-14.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 or Problem Description
Dislocation head from liner (no loosening) after 2 months from the primary surgery.Femoral head has been successfully revised.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 32 SIZE S -3.5
• Common Device Name: BALL HEADS: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11138889
• Report Number: 3005180920-2021-00022
• Device Sequence Number: 845769
• Product Code: JDI
• UDI-Device Identifier: 07630030805158
• UDI-Public: 07630030805158
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 01/08/2021

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: 06/18/2025
• Device Model Number: 01.25.021
• Device Catalogue Number: 01.25.021
• Device Lot Number: 2001940
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 72