MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 Ø 22 SIZE S -2,5; HIP ACETABULAR HEAD COCR

Model Number	01.25.124
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 years and 4 months after the primary surgery, the patient came in reporting pain due to a dislocation of the head from the liner and the cause of the dislocation is unknown.The surgeon revised the head and liner and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 179171: 30 items manufactured and released on (b)(6) 2018.Expiration date: 2023-02-21.No anomalies found related to the problem.To date, 23 items of the same lot have been sold with no similar reported case during the period of review.Additional component involved: liner: versafitcup dm 01.26.2246mhc double mobility hc liner ø 46/22.2 (k092265) lot 152097: 36 items manufactured and released on (b)(6) 2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, 31 items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø 22 SIZE S -2,5
• Common Device Name: HIP ACETABULAR HEAD COCR
• 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: 15438731
• Report Number: 3005180920-2022-00690
• Device Sequence Number: 12154837
• Product Code: JDI
• UDI-Device Identifier: 07630030805486
• UDI-Public: 07630030805486
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080885
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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: 02/21/2023
• Device Model Number: 01.25.124
• Device Catalogue Number: 01.25.124
• Device Lot Number: 179171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2018
• 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 Sex: Female