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

Model Number	10-10-0004
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/12/2019
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.Post-operative fractures may be multifactorial and can depend on patient bone quality and physical activity.From the nextstep arthropedix insitu total hip system instructions for use (ifu): "the patient must be informed that the same demands cannot be made of artificial joints as of real ones.".
Event or Problem Description
A revision surgery was conducted and the stem and head were explanted and a competitor's stem was implanted.The patient claims there were no post-op events or falls, and the post-op x-ray looked satisfactory according to the surgeon.The surgeon believes there was a possible unidentified inter-operative 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: 8995821
• Report Number: 3002498892-2019-00013
• Device Sequence Number: 2820094
• Product Code: LPH
• UDI-Device Identifier: 00816127021978
• UDI-Public: 00816127021978
• 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): 09/11/2019

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: 09/01/2022
• Device Model Number: 10-10-0004
• Device Catalogue Number: 10-10-0004
• Device Lot Number: 1294
• 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: 09/11/2019
• 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: 67 YR