MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD Ø28X51

Model Number	25060.2851
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed 1 month after the primary due to intra-prosthetic dislocation.Several attempts of closed reduction were performed on the patient to try to resolve the dislocation.The surgeon revised the bipolar head, ceramic head, and stem which appeared to be loose due to aggressive maneuvers of close reduction.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 05 april 2022: lot 186812: (b)(4).Expiration date: 2023-11-22.No anomalies found related to the problem.(b)(4).Additional items involved in the event: ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 (k112115) lot.178983.Batch review performed on 05 april 2022: lot 178983: (b)(4).Expiration date: 2023-04-02.No anomalies found related to the problem.(b)(4).Stem: quadra-p 01.12.232 quadra-p cemented lat stem size 2 (k192827) lot.2002222 batch review performed on 06 april 2022: lot 2002222: (b)(4).Expiration date: 2025-05-12.No anomalies found related to the problem.(b)(4).

• Brand Name: BALL HEADS: BIPOLAR HEAD Ø28X51
• Common Device Name: BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 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: 14039889
• Report Number: 3005180920-2022-00246
• Device Sequence Number: 6298202
• Product Code: KWY
• UDI-Device Identifier: 07630030843730
• UDI-Public: 07630030843730
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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: 11/22/2023
• Device Model Number: 25060.2851
• Device Catalogue Number: 25060.2851
• Device Lot Number: 186812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2018
• 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 Sex: Male