MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 32 SIZE M 0

Model Number	01.25.022
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-nov-2019: lot 1901507: 150 items manufactured and released on 02-jul-2019.Expiration date: 19/06/2024.No anomalies found related to the problem.To date, 83 items of the same lot have been already sold without any other similar reported event.Additional device involved.Batch review performed on 11-nov-2019: lot 1901462: 220 items manufactured and released on 25-apr-2019.Expiration date: 13/04/2024.No anomalies found related to the problem.To date, 136 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient had a primary hip surgery and was implanted with all competitor items.The date of the primary hip surgery is unknown.Subsequently, the patient came in complaining of pain and the cause of the pain was unknown.The surgeon removed the competitor implants and implanted the patient with a medacta head, cup, and liner.The surgery was completed successfully.Presently, on (b)(6) 2019 (1 month after the first revision surgery), the patient came in complaining of pain caused by a dislocation of the head from the liner.The surgeon revised the cup, liner, and head and the surgery was completed successfully.
Additional Manufacturer Narrative
On 14-jan-2021 we discovered the gender of the patient involved in this case.During follow up prepration we noticed that the details of the second device involved were not reported, so they are detailed below: additional device involved.Liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.1901462 batch review performed on 11-nov-2019: lot 1901462: 220 items manufactured and released on 25-apr-2019.Expiration date: 13/04/2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Also, an error was noticed in section d2 , "common device name".It has been corrected reporting the actual common device name of the device.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 32 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: 9304129
• Report Number: 3005180920-2019-00963
• Device Sequence Number: 10902754
• Product Code: JDI
• UDI-Device Identifier: 07630030805165
• UDI-Public: 07630030805165
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

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: 06/19/2024
• Device Model Number: 01.25.022
• Device Catalogue Number: 01.25.022
• Device Lot Number: 1901507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 02/08/2021
• 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