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

Model Number 01.25.021

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 05/09/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 16 may 2023: lot 2108058: 120 items manufactured and released on 16-sep-2021.Expiration date: 2026-sep-06.No anomalies found related to the problem.To date, 107 items of the same lot have been sold with 1 similar reported event during the period of review.Additional device involved cup: mpact 01.32.150dh acetabular shell ø50 two-holes (k132879) lot 2218064: (b)(4) items manufactured and released on 11-nov-2022.Expiration date: 2027-oct-30.No anomalies found related to the problem.To date, 23 items of the same lot have been sold with no similar reported event during the period of review.Liner: mpact 01.32.3241hcat hooded pe hc liner ø32/d (k132879) lot 2218086: (b)(4) items manufactured and released on 29-sep-2022.Expiration date: 2027-sep-08.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with 1 similar reported event during the period of review.Stem: sms solid 01.36.044 sms solid stem std sizue 4 (k181693) lot 2106261: (b)(4) items manufactured and released on 29-sep-2021.Expiration date: 2026-sep-07.No anomalies found related to the problem.To date, 29 items of the same lot have been sold with no similar reported event during the period of review.Screws: mpact 01.43.0025 cancellous bone screw ø 6,5 l 25 (k200391) lot 2216103: (b)(4) items manufactured and released on 13-oct-2022.Expiration date: 2027-sep-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

Event Description

The patient came in due to signs of an infection and the pathogen is unknown.About 2 months and 10 days after the primary surgery, the surgeon removed all components and implanted permanent hardware.The surgery was completed successfully.

• Brand Name: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5
• Type of Device: HIP BALL HEAD
• 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: 17037725
• MDR Text Key: 316299852
• Report Number: 3005180920-2023-00410
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030805158
• UDI-Public: 07630030805158
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2023

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 Model Number: 01.25.021
• Device Catalogue Number: 01.25.021
• Device Lot Number: 2108058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2021
• 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 Sex: Female