MAUDE Adverse Event Report: CONSENSUS ORTHOPEDICS, INC. BIPOLAR ASSEMBLY

Catalog Number 1015-0-4850

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

Dhr review was performed.No product evaluation has yet been performed.Explant was not returned at the time of this initial report.No x-rays were provided by hospital for evaluation.

Event Description

On (b)(6) 2019 this patient presented at the (b)(6) emergency dept.After sustaining a "hard fall".Clinical evaluation and x-ray findings yielded a diagnosis of a bipolar hip replacement which was reached and the decision was made by the emergency room physician to attempt a reduction of the dislocation.At some point during the attempted reduction, disassociation of the 28mm femoral head from the bi-polar insert occurred.The patient was then admitted to (b)(6) m.D.For further evaluation and treatment at (b)(6).

Manufacturer Narrative

Added to h10: an engineering evaluation has been performed.

• Brand Name: BIPOLAR ASSEMBLY
• Type of Device: BIPOLAR ASSEMBLY
• Manufacturer (Section D): CONSENSUS ORTHOPEDICS, INC.; 1115 windfield way; el dorado hills CA 95762
• MDR Report Key: 8927045
• MDR Text Key: 155503638
• Report Number: 2952369-2019-00005
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00844588002373
• UDI-Public: 00844588002373
• Combination Product (y/n): N
• PMA/PMN Number: K922560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

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: 12/06/2022
• Device Catalogue Number: 1015-0-4850
• Device Lot Number: 485712
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 07/26/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR