MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 28 SIZE XL +7

Catalog Number	01.25.014
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 24 july 2018.Lot 154620: (b)(4) items manufactured and released on 16 december 2015.Expiration date: 2020-11-18.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.Visual inspection performed on the 18th july 2018 by washing & packaging manager and technical director, assisted by medacta complaint specialist.The device was inspected and the presence of a black sign is confirmed.The black sign is likely to be caused by a too high force applied to the measuring gauge used to control the ball head cone depth just before the packaging.The jig used for this lot of femoral heads was made of black pom-c, a plastic medical grade material, and the 'drop' signs is likely to be due to the evaporation of the alcohol used to sanitize it prior to use.From the june 2017 this gauge is no longer used and it has been replaced by a stainless steel caliber.
Event or Problem Description
A black sign was found in the internal part of the cocr ball head, a ceramic head was used to complete the surgery.In addition, the surgeon suggested to modify the picture on the implant label; it is without the collar while the implant has it.

• Brand Name: COCR BALL HEAD 12/14 Ø 28 SIZE XL +7
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7722405
• Report Number: 3005180920-2018-00550
• Device Sequence Number: 19058594
• Product Code: JDI
• UDI-Device Identifier: 07630030805134
• UDI-Public: 07630030805134
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2020
• Device Catalogue Number: 01.25.014
• Device Lot Number: 154620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/26/2018
• 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: Other
• Patient Age: 74 YR
• Patient Weight: 88