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

Catalog Number	1020-0-2843
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discussion: the incident, involving the patient's fall while going to the bathroom, was evaluated for possible cause of hip dislocation.The bipolar head most likely dislocated from the acetabulum due to the patient falling prior to entering the emergency room and prior to manipulation.The surgeon's attempt at manipulating the hip, most likely lead to component dissociation, however this was unrelated to the incident of the patient falling.Due to limited information on how the patient fell, it is unknown what mechanism caused the bipolar head to dislocate from the hip socket.The preassembled bipolar head and unisyn stem were apparently functioning as intended prior to the fall.The dhr review revealed no abnormalities pertaining to qc inspection or processing of the implant components used in primary surgery.Radiographs indicated adequate component assembly and positioning in the patient at time of primary surgery.There were no indications of component dissociation prior to the surgeon's attempt at manipulating the hip.In summary, the actual cause of the bipolar head dislocation from the hip socket remains inconclusive.
Event or Problem Description
Disassociation of the femoral head from bipolar lining.

• 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: 8516147
• Report Number: 2952369-2019-00001
• Device Sequence Number: 1466151
• Product Code: KWY
• UDI-Device Identifier: 00844588016103
• UDI-Public: 00844588016103
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2019

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: 09/19/2021
• Device Catalogue Number: 1020-0-2843
• Device Lot Number: 830667A2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/15/2019
• 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: Required Intervention
• Patient Age: 53 YR