MAUDE Adverse Event Report: THEKEN COMPANIES MEXTSTEP ARTHROPEDIX; INSITU HIP SYSTEM

Model Number	10-11-0004
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: the femoral stem subsided and was loose resulting in thigh pain after being implanted for 3 months.This is most likely due to an undersize stem implanted during the initial surgery.A revision surgery was performed to implant a larger sized stem.This mdr is resubmitted because initial mdr had failed processing.It was not realized until the acknowledged forms were reviewed during the fda audit.It was found out that mfg report number was repeated.Acknowledgement message did not say fail in the message body so it was not detected.
Event or Problem Description
Patient presented with thigh pain 3 months post-op.Patient was examined by x-ray and found femoral stem had loosened.Revision surgery was performed replacing the stem and head components only.

• Brand Name: MEXTSTEP ARTHROPEDIX
• Common Device Name: INSITU HIP SYSTEM
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron OH 44306
• MDR Report Key: 8191598
• Report Number: 3002498892-2017-00007
• Device Sequence Number: 1997521
• Product Code: LPH
• UDI-Device Identifier: 00816127022111
• UDI-Public: 00816127022111
• Combination Product (Y/N): N
• PMA/510(K) Number: K161184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2017

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: No Information
• Device Expiration Date: 10/01/2018
• Device Model Number: 10-11-0004
• Device Catalogue Number: 10-11-0004
• Device Lot Number: PC006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR