MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE M 0; HIP FEMORAL HEAD

Model Number	01.25.031
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 11 months after the primary surgery, the patient came in reporting pain and the cause is unknown.The surgeon revised all components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 01-jun-2023.Lot 186285: (b)(4) items manufactured and released on 07-nov-2018.Expiration date: 2023-10-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional component involved: cup: mpact 01.32.156dh acetabular shell ø56 two-holes (k132879) lot 2009438: (b)(4) items manufactured and released on 10-dec-2020.Expiration date: 2025-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot 2011808: (b)(4) items manufactured and released on 10-dec-2020.Expiration date: 2025-11-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Stem: sms solid 01.36.048 sms solid stem std size 8 (k181693) lot 1910766: (b)(4) items manufactured and released on 30-apr-2020.Expiration date: 2025-04-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE M 0
• Common Device Name: HIP FEMORAL 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: 17038546
• Report Number: 3005180920-2023-00412
• Device Sequence Number: 6516312
• Product Code: JDI
• UDI-Device Identifier: 07630030805219
• UDI-Public: 07630030805219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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: 10/24/2023
• Device Model Number: 01.25.031
• Device Catalogue Number: 01.25.031
• Device Lot Number: 186285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2018
• 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 Age: 69 YR
• Patient Sex: Male