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

Model Number	10-10-0006
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/14/2019
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.Based on the information provided, 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 believed he identified an intra-operative fracture after inserting the stem.He removed the stem, utilized circlage cable, and reinserted the stem.Upon reinserting the stem the fracture was more apparent and the stem subsided.The stem was removed again and a competitor's stem was implanted.

• 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: 9040488
• Report Number: 3002498892-2019-00014
• Device Sequence Number: 11276320
• Product Code: LPH
• UDI-Device Identifier: 00816127022135
• UDI-Public: 00816127022135
• 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
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

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: 04/01/2023
• Device Model Number: 10-10-0006
• Device Catalogue Number: 10-10-0006
• Device Lot Number: 1325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/13/2019
• 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: 73 YR