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

Model Number	01.25.031
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 december 2020: lot 187961: (b)(4) items manufactured and released on 17-jan-2019.Expiration date: 2024-01-07.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.Additional device involved: batch review performed on 21 december 2020: liner: mpact 01.32.3644hc10a face-changing 10deg pe hc liner 36/e (k183582)lot.1810850: (b)(4) items manufactured and released on 22-mar-2019.Expiration date: 2024-03-10.No anomalies found related to the problem.To date, 10 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in, 2 months after primary surgery, reporting pain due to a dislocation of the head from the liner.The surgeon revised the medacta head with a medacta head and revised the medacta liner and cup with another company's product.The surgery was completed successfully.A direct anterior approach was used in the primary surgery.

• Brand Name: BALL HEADS: COCR 12/14 36 SIZE M 0
• Common Device Name: BALL HEAD COCR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11176900
• Report Number: 3005180920-2021-00043
• Device Sequence Number: 2397896
• Product Code: JDI
• UDI-Device Identifier: 07630030805219
• UDI-Public: 07630030805219
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K080885
• 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): 01/15/2021

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: 01/07/2024
• Device Model Number: 01.25.031
• Device Catalogue Number: 01.25.031
• Device Lot Number: 187961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/15/2021
• 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: 87 YR