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

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Inflammation (1932)

Event Date 06/27/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 319653733
• Report Number: 3005180920-2023-00548
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030805226
• UDI-Public: 07630030805226
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K080885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 01.25.032
• Device Lot Number: 121068
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White