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

Catalog Number	1015-0-4850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional Manufacturer Narrative
Added to h10: an engineering evaluation has been performed.

• Brand Name: BIPOLAR ASSEMBLY
• Common Device Name: BIPOLAR ASSEMBLY
• Manufacturer (Section D): CONSENSUS ORTHOPEDICS, INC.; 1115 windfield way; el dorado hills CA 95762
• MDR Report Key: 8927045
• Report Number: 2952369-2019-00005
• Device Sequence Number: 2128384
• Product Code: KWY
• UDI-Device Identifier: 00844588002373
• UDI-Public: 00844588002373
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K922560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR