MAUDE Adverse Event Report: THEKEN COMPANIES INSITU TOTAL HIP SYSTEM; TOTAL HIP ARTHROPLASTY

Model Number	10-10-0007
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are no other complaints associated with the referenced lot numbers.X-rays were not received from the health professional.Use of cables was a preventive measure as no fracture was identified.No post-operative complaints reported for the implanted components.Based on the information provided, potential fracture cannot be attributed to the implant.Intra-operative fractures may be multifactorial and can depend on patient bone quality and surgeon technique.From the nextstep arthropedix insitu total hip system instructions for use (ifu): "before any implant is used, the surgeon should be completely familiar with all aspects of the surgical procedure and the limitations of the device.".
Event or Problem Description
During the primary hip arthroplasty the surgeon noticed that the stem seated more distal relative to the broach.No fracture reported.As a prophylactic measure the surgeon elected to install cerclage cables to prevent subsidence and potential periprosthetic fracture.

• Brand Name: INSITU TOTAL HIP SYSTEM
• Common Device Name: TOTAL HIP ARTHROPLASTY
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron OH 44306
• MDR Report Key: 9565621
• Report Number: 3002498892-2020-00001
• Device Sequence Number: 2755895
• Product Code: LPH
• UDI-Device Identifier: 00816127022005
• UDI-Public: 00816127022005
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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: 02/01/2023
• Device Model Number: 10-10-0007
• Device Catalogue Number: 10-10-0007
• Device Lot Number: 1077C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/08/2020
• 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: Required Intervention
• Patient Age: 55 YR