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
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2023-00410
• Device Sequence Number: 12376952
• Product Code: JDI
• UDI-Device Identifier: 07630030805158
• UDI-Public: 07630030805158
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2026
• Device Model Number: 01.25.021
• Device Catalogue Number: 01.25.021
• Device Lot Number: 2108058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2021
• 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 Sex: Female