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

Device Problem Device Appears to Trigger Rejection (1524)

Event Date 05/05/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 316389266
• Report Number: 3005180920-2023-00412
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030805219
• UDI-Public: 07630030805219
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080885
• 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 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
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2018
• 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: 69 YR
• Patient Sex: Male