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
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Disorder (2373)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: HIP FEMORAL COCR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9334638
• Report Number: 3005180920-2019-00972
• Device Sequence Number: 1927721
• Product Code: JDI
• UDI-Device Identifier: 07630030805158
• UDI-Public: 07630030805158
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2019

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: 11/25/2023
• Device Catalogue Number: 01.25.021
• Device Lot Number: 187058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/18/2019
• 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
• Patient Age: 55 YR
• Patient Weight: 64