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

Model Number	10-10-0004
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	08/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is one other fracture complaint associated with devices from this lot, but the surgeon from the prior complaint believes there was a missed intra-operative fracture.X-rays were not received from the health professional for this complaint, though it was stated that they were taken 6 days post-op.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
The patient lost balance and sat down hard in her wheelchair while standing up, causing a femur fracture.X-rays were taken 6 days post-operatively.

• 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: 9100648
• Report Number: 3002498892-2019-00015
• Device Sequence Number: 11472273
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

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: 08/27/2019
• Initial Report FDA Received Date: 09/20/2019
• 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: 58 YR