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

Model Number	10-40-3654
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are no other complaints associated with the referenced lot numbers.The cause for dislocation resulting from instability is multifactorial, including, but not limited to, surgical technique and patient compliance.Dislocation occurred during rigorous activity.Per the ifu the same demands of a healthy hip joint cannot be expected from total hip arthroplasty components.The surgeon revised the femoral head with a higher offset version and revised the liner to a hooded version to add more stability to the patient's joint.
Event or Problem Description
Patient's hip was revised to treat instability/dislocation that resulted from rigorous activity.The femoral head was replaced with a higher offset version and the neutral liner was replaced with a hooded liner.

• 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: 11028076
• Report Number: 3002498892-2020-00010
• Device Sequence Number: 1024218
• Product Code: LPH
• UDI-Device Identifier: 00816127022753
• UDI-Public: 00816127022753
• Combination Product (Y/N): N
• PMA/510(K) Number: K161184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/17/2020

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: 08/01/2024
• Device Model Number: 10-40-3654
• Device Lot Number: 1492
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 12/17/2020
• 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: 64 YR