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

Catalog Number	01.25.032
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 4 july 2023.Lot 121068: (b)(4) items manufactured and released on 12-apr-2012.Expiration date: 2017-feb-28.No anomalies found related to the problem.To date, all items of the same lot (considering also resterilized pieces) have been sold with no similar reported event during the period of review.Addtional device involved: batch review performed on 4 july 2023 on stem: amistem h 01.18.132 ha coated std stem size 2 (k093944) lot.155651: (b)(4) items manufactured and released on 19-jan-2016.Expiration date: 2021-jan-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot (considering also resterilized pieces) have been sold with no similar reported event during the period of review.
Event or Problem Description
Revision due to inflammation for suspected trunnionosis, about 6 years and 6 months after the primary surgery.Cup, liner, and head revised.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5
• Common Device Name: HIP COCR BALL HEADS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17387413
• Report Number: 3005180920-2023-00548
• Device Sequence Number: 17694928
• Product Code: JDI
• UDI-Device Identifier: 07630030805226
• UDI-Public: 07630030805226
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• 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): 07/25/2023

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: 02/28/2017
• Device Catalogue Number: 01.25.032
• Device Lot Number: 121068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White