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

Model Number	10-41-3662
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Arthralgia (2355); Metal Related Pathology (4530)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient had existing bilateral total hip replacements.The first surgery was performed in 2018; the patient received an insitu cementless femoral stem, cocr femoral head, neutral acetabular liner, acetabular cup, and acetabular bone screws.The second procedure was performed on the contralateral side in 2020; the patient received an insitu blade femoral stem, ceramic femoral head, hooded acetabular liner, acetabular cup, and acetabular bone screws.In 2025, the patient presented with pain to the revising surgeon.The distributor reported to nextstep arthropedix that the revising surgeon suspected an adverse local tissue reaction in the periprosthetic tissue based on the existing implant femoral head material (cocr) and therefore ordered serum testing to measure the cobalt and chromium ion levels.The surgeon reported that serum cobalt ion levels were elevated.The cocr femoral head and acetabular liner from the 2018 procedure were ultimately revised.During the revision procedure, the surgeon reported visible evidence of an adverse local tissue reaction in the periprosthetic space.Adverse local tissue reaction is a potential and known risk for total hip replacement devices.Per the instructions for use - "inadequate preclosure cleaning (removal of surgical debris) can lead to excessive wear.Improper preoperative or intraoperative implant handling or damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, fatigue fracture and/or excessive wear." the revising surgeon elected to leave the insitu femoral stem and acetabular cup in-situ, replaced the neutral liner with a hooded liner, and used a competitor's ceramic head.Ncms and the dhr were reviewed.There are no reported ncms for the subject lots and the devices were found to be within specification.There are no similar complaints reported for other components from the same lots.The components were not returned, therefore nextstep was not able to perform corrosion assessments to determine if corrosion was present and potentially linked to the reported adverse local tissue reaction.
Event or Problem Description
It was reported that a cocr femoral head and acetabular liner were revised in a patient that presented with pain.

• Brand Name: INSITU TOTAL HIP SYSTEM
• Common Device Name: HOODED LINER
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron OH 44306
• Manufacturer Contact: jenna amawi ; 1800 triplett blvd; akron, OH 44306 ; 3307337600
• MDR Report Key: 23329363
• Report Number: 3002498892-2025-00020
• Device Sequence Number: 13239144
• Product Code: LPH
• UDI-Device Identifier: 00816127022883
• UDI-Public: 00816127022883
• Combination Product (Y/N): N
• PMA/510(K) Number: K161184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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: 11/01/2018
• Device Model Number: 10-41-3662
• Device Lot Number: PC344
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETABULAR CUP.; HOODED LINER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male