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

Model Number	10-10-0006
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are no reported issues with other components from this lot.Stem subsidence and post-operative periprosthetic fracture is multifactorial, including but not limited to trauma, surgical technique, patient compliance, and bone quality.Bone fracture cannot be attributed to design malfunction based on details provided.
Event or Problem Description
Two-weeks post-op the patient heard a pop while getting off the toilet.Xray showed a periprosthetic femur fracture and significant stem subsidence.Surgeon revised the stem only with a competitor stem.

• 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: 12175853
• Report Number: 3002498892-2021-00006
• Device Sequence Number: 5097305
• Product Code: LPH
• UDI-Device Identifier: 00816127021992
• UDI-Public: 00816127021992
• Combination Product (Y/N): N
• PMA/510(K) Number: K161184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 02/01/2026
• Device Model Number: 10-10-0006
• Device Catalogue Number: 10-10-0006
• Device Lot Number: 2568
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/15/2021
• 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: 85 YR