MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5

Catalog Number	01.25.032
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 october 2019: lot: 1900782: 45 items manufactured and released on 05-jun-2019.Expiration date: 2024-05-22.No anomalies found related to the problem.To date, 16 items of the same lot have been already sold without any other similar reported event.Another device involved in the case: liner: mpact 01.32.3652hct flat pe hc liner 36/g lot.1810222 (k103721).Batch review performed on 22 october 2019: lot: 1810222: 40 items manufactured and released on 10-dec-2018.Expiration date: 2023-11-28.No anomalies found related to the problem.To date, 21 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed 1 day after the primary due to dislocation (head from the liner).The surgeon revised the stem masterloc lateralized #10 with a masterloc lateralized #12, the 36mm cocr head l with a 40mm biolox delta head l, and the mpact flat liner hc 36/g with a mpact flat liner hc 40/g.The surgery was completed successfully.The surgeon uses orthoview templating.The femoral head and neck were anteriorly rotated and the patient the dislocated anteriorly.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9278374
• Report Number: 3005180920-2019-00942
• Device Sequence Number: 19366118
• Product Code: JDI
• UDI-Device Identifier: 07630030805226
• UDI-Public: 07630030805226
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

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: 05/22/2024
• Device Catalogue Number: 01.25.032
• Device Lot Number: 1900782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/05/2019
• 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