MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HIGH INSIGNIA COLLARED HIP STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	7000-6606
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
"reported event: an event regarding periprosthetic fracture involving an insignia stem was reported.The event was confirmed via medica review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: ""i can confirm that the patient underwent the primary hip arthroplasty and that the patient sustained a periprosthetic fracture since i was able to review an x-ray which showed the clinical situation.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of periprosthetic fracture within a few weeks after surgery are multifactorial including surgical technique.It is possible that the broach and implant was too large for the bone envelope and that a fissure occurred that perhaps was unrecognized and it progressed to a periprosthetic fracture.Trauma can also play a role but none was reported.Patient activity level and bmi could also play a role.With the information provided i would not assign any causality to the implant itself.N.B.Any and all explanted parts or prostheses should be submitted to stryker engineers for complete metallurgical and/or microscopic evaluation and analysis."" -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to periprosthetic fracture.""i can confirm that the patient underwent the primary hip arthroplasty and that the patient sustained a periprosthetic fracture since i was able to review an x-ray which showed the clinical situation.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of periprosthetic fracture within a few weeks after surgery are multifactorial including surgical technique.It is possible that the broach and implant was too large for the bone envelope and that a fissure occurred that perhaps was unrecognized and it progressed to a periprosthetic fracture.Trauma can also play a role but none was reported.Patient activity level and bmi could also play a role.With the information provided i would not assign any causality to the implant itself.N.B.Any and all explanted parts or prostheses should be submitted to stryker engineers for complete metallurgical and/or microscopic evaluation and analysis." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.".
Event or Problem Description
The following information was provided: patient's hip revised due to periprosthetic femoral fracture.No other information available due to hospital policy.

• Brand Name: HIGH INSIGNIA COLLARED HIP STEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 24433782
• Report Number: 0002249697-2026-00118
• Device Sequence Number: 16028084
• Product Code: JDI
• UDI-Device Identifier: 07613327511406
• UDI-Public: 07613327511406
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K250989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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 Catalogue Number: 7000-6606
• Device Lot Number: 33841253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 79 YR
• Patient Sex: Male