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

Model Number	01.25.031
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regualtory affairs department on 2 october 2020 lot 186285: (b)(4) items manufactured and released on 7-nov-2018.Expiration date: 2023-10-24.No anomalies found related to the problem.To date, 46 items of the same lot have been already sold without any similar reported event.Other devices involved in the event: liner: mpact 01.32.3652hct flat pe hc liner ø36/g lot.2000184 (k103721).Batch review performed by medacta regualtory affairs department on 2 october 2020 lot 2000184:(b)(4) items manufactured and released on 10-mar-2020.Expiration date: 2025-02-19.No anomalies found related to the problem.To date, 11 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
After the primary hip surgery, when the patient was being transferred to another bed, the patient's hip dislocated (the head dislocated from the liner).One day after the primary surgery, the surgeon revised the masterloc cementless mectagrip stem std #7 with a masterloc cementless mectagrip stem lat plus #7 and the 36mm cocr head m with a 36mm cocr head xl.The surgery was completed successfully.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 36 SIZE M 0
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10705416
• Report Number: 3005180920-2020-00718
• Device Sequence Number: 19760161
• Product Code: JDI
• UDI-Device Identifier: 07630030805219
• UDI-Public: 07630030805219
• Combination Product (Y/N): Y
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2020

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: 10/24/2023
• Device Model Number: 01.25.031
• Device Catalogue Number: 01.25.031
• Device Lot Number: 186285
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/20/2020
• 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