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

Model Number	10-21-3601
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient develope disinfection post operatively.Surgeon scheduled a complete explantation, irrigation and debridement, antibiotics and replacement implants.There is no indication of a malfunction of the implants and a source of the infection was not determined.All 4 components were replaced.Original implanted devices were femoral head 10-21-3601; lot # 7011138738, femoral stem 10-11-0007; lot # 1087, acetabular cup 10-32-0058; lot # 1034, acetabular liner 10-40-3658; lot # 1060.These lot numbers were compared for previous complaints on infection.These product lots are different.No lots matched.Therefore, there is no reason to suspect any issues with product contamination.Exact cause of infection is unknown.
Event or Problem Description
Patient hip system was revised due to infection.Complete washout, complete explantation and reimplantation of new components along with antibiotic powder.

• Brand Name: NEXTSTEP ARTHROPEDIX
• Common Device Name: INSITU HIP SYSTEM
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron OH 44306
• MDR Report Key: 7143696
• Report Number: 3002498892-2017-00006
• Device Sequence Number: 19057791
• Product Code: LPH
• UDI-Device Identifier: 00816127022494
• UDI-Public: 00816127022494
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 04/01/2022
• Device Model Number: 10-21-3601
• Device Catalogue Number: 10-21-3601
• Device Lot Number: 7011138738
• 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: 09/07/2017
• Initial Report FDA Received Date: 12/22/2017
• 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: Life Threatening
• Patient Age: 51 YR