MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5; HIP FEMORAL COCR HEAD

Catalog Number 01.25.021

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Unspecified Infection (1930); Joint Disorder (2373)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 4 november 2019: lot 187058: 170 items manufactured and released on 8-dec-2018.Expiration date: 2023-11-25.No anomalies found related to the problem.To date, 147 items of the same lot have been already sold without any similar reported event.Batch reviews performed on 30 october 2019: stem: quadra-c 01.12.054 cemented, mirror polishing lat stem size 4 12/14 (k083558) lot 171586: 30 items manufactured and released on 20-gun-2017.Expiration date: 2022-05-31.No anomalies found related to the problem.To date, 18 items of the same lot have been already sold without any similar reported event.The loose hip shell is not marketed in the usa.

Event Description

Revision surgery performed 2,5 months after the primary due to loose stem and cup.All implants were revised.The patient was in isolation because of mrsa infection and he also has a long history of diseases.It is unknown what was the primary reason of the revision surgery (infection, pain or implants loosening).

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5
• Type of Device: HIP FEMORAL COCR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 9334638
• MDR Text Key: 168046441
• Report Number: 3005180920-2019-00972
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030805158
• UDI-Public: 07630030805158
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K072857
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2023
• Device Catalogue Number: 01.25.021
• Device Lot Number: 187058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/08/2018
• 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: 55 YR
• Patient Weight: 64