MAUDE Adverse Event Report: CONSENSUS ORTHOPEDICS, INC. BIPOLAR ASSEMBLY; BIPOLAR ASSEMBLY, PRUDUCT CODE: KWY

Catalog Number	1020-0-2849
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discussion.The incident, involving the patient's fall was evaluated for possible cause of hip dislocation and femoral head dissociation.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 er doctor's attempt at manipulating the hip, most likely lead to component dissociation, however this would have been unrelated to the incident of the patient falling.Radiographs confirmed a dislocated hip in the er, but it was not reported whether the radiographs were taken before or after manipulation.Radiographs also confirmed a partial femoral head dissociation, but did not confirm the cause due to the patient falling or manipulation.Due to the lack of information on how or why the patient fell, it is unknown what mechanism caused the bipolar head to dislocate from the hip socket.The preassembled bipolar head and chs 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.Post-op radiographs at time of primary surgery were not retrieved and thus it was not possible to assess component assembly and positioning at time of primary surgery.Furthermore, it was not possible to assess whether the femoral dissociation occurred before or after manipulation leading up to revision surgery.In summary, the actual cause of the bipolar head dislocation from the hip socket and femoral head dissociation from the bipolar head remains inconclusive.
Event or Problem Description
Bipolar was put (implanted) in patient on (b)(6) 2019.Patient fell on (b)(6) 2019.Patient went to er (emergency room) on (b)(6) 2019.My understanding from dr.(b)(6) is that the patient was dislocated when she came in.The er doctor on call tried to manipulate hip to get back into place.

• Brand Name: BIPOLAR ASSEMBLY
• Common Device Name: BIPOLAR ASSEMBLY, PRUDUCT CODE: KWY
• Manufacturer (Section D): CONSENSUS ORTHOPEDICS, INC.; 1115 windfield way; el dorado hills CA 95762
• MDR Report Key: 8833992
• Report Number: 2952369-2019-00002
• Device Sequence Number: 16221038
• Product Code: KWY
• UDI-Device Identifier: 00844588016165
• UDI-Public: 00844588016165
• 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): 07/01/2019

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: 03/22/2022
• Device Catalogue Number: 1020-0-2849
• Device Lot Number: 832079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/26/2019
• 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