MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD Ø28X50; HIP BIPOLAR HEAD

Model Number 25060.2850

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 07/27/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2022 lot 2108688: 103 items manufactured and released on 31-aug-2021.Expiration date: 2026-08-16.No anomalies found related to the problem.To date, 84 items of the same lot have been sold without any similar reported event during the period of review.

Event Description

At 23 days after the primary, the patient came in reporting pain due to a dislocation of the bipolar cup and femoral head from the acetabulum.The surgeon revised the bipolar cup and femoral head.The surgery was completed successfully.

Event Description

At 23 days after the primary, the patient came in reporting pain due to a dislocation of the bipolar cup and femoral head from the acetabulum that was caused from falling.The surgeon revised the bipolar cup and femoral head.The surgery was completed successfully.

• Brand Name: BALL HEADS: BIPOLAR HEAD Ø28X50
• Type of Device: HIP BIPOLAR 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: 15300397
• MDR Text Key: 298667259
• Report Number: 3005180920-2022-00646
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07630030843716
• UDI-Public: 07630030843716
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091967
• 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,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25060.2850
• Device Catalogue Number: 25060.2850
• Device Lot Number: 2108688
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Female