MAUDE Adverse Event Report: CONSENSUS ORTHOPEDICS, INC. UNISYN HIP SYSTEM; STRAIGHT FLUTED LONG STEM TI 16MMX190MM

Model Number	3422-11619-0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Missing Value Reason (3192)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is initial report, follow-up pending evaluation.Awaiting further information.An engineering evaluation is underway however the explanted hip stem has not been returned for evaluation nor have any x-rays been provided from complainant.
Event or Problem Description
Per aesculap complaint report (b)(4): it was reported by the legal department on 06may2020, that as a result of having an aesculap hip system implanted, the patient has experienced, fracture of the femoral stem, on approximately (b)(6) 2018 the patient's left hip popped and he fell, which resulted in a revision surgery.The primary surgery occurred around (b)(6) 2010, and the revision surgery occurred on, (b)(6) 2019.Based on the information provided the surgeon associated with the reported event was listed as, dr.(b)(6), and the patient associated with the reported event was listed with the initials of, (b)(6).
Additional Manufacturer Narrative
H10.Initial report was sent prior to engineering evaluation completion.Engineering evaluation m20-005 is being provided in the follow-up report.

• Brand Name: UNISYN HIP SYSTEM
• Common Device Name: STRAIGHT FLUTED LONG STEM TI 16MMX190MM
• Manufacturer (Section D): CONSENSUS ORTHOPEDICS, INC.; 1115 windfield way; el dorado hills, ca
• MDR Report Key: 10117159
• Report Number: 2952369-2020-00001
• Device Sequence Number: 13893688
• Product Code: LPH
• UDI-Device Identifier: 00844588008894
• UDI-Public: 00844588008894
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K003649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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: 03/15/2012
• Device Model Number: 3422-11619-0
• Device Catalogue Number: 3422-11619-0
• Device Lot Number: 490210AB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 07/28/2020
• 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: 64 YR