MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0; HIP METALLIC FEMORAL HEAD

Model Number	01.25.012
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 june 2022.Lot 157162: (b)(4) items manufactured and released on 25-feb-2016.Expiration date: 2021-02-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Lot 187713: (b)(4) items manufactured and released on 25-jan-2019.Expiration date: 2024-01-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At 2 years and 9 months after the primary, the patient came in reporting pain and the cause is unknown.The surgeon revised medacta cocr head and bipolar head.The surgeon implanted a competitor cup and liner and a medacta head and sleeve.The surgery was completed successfully.
Additional Manufacturer Narrative
Follow-up to correct the batch review of the second implant involved in the complaint that was reported without k number and description of the device due to human error.The other device involved in the complaint : ball heads: bipolar head 25060.2844 bipolar head ø28x44 (k091967) lot.187713: (b)(4) items manufactured and released on 25-jan-2019.Expiration date: 2024-01-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0
• Common Device Name: HIP METALLIC FEMORAL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14683542
• Report Number: 3005180920-2022-00462
• Device Sequence Number: 14630813
• Product Code: JDI
• UDI-Device Identifier: 07630030805110
• UDI-Public: 07630030805110
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

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: 02/13/2021
• Device Model Number: 01.25.012
• Device Catalogue Number: 01.25.012
• Device Lot Number: 157162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2016
• 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