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

Catalog Number	7000-6603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Periprosthetic fracture (4902)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following information was provided: patient's left hip revised due to periprosthetic fracture.No other information available due to hospital policy.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving an insignia stem was reported.The event was confirmed via medical 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: "conclusion/assessment: no medical data, history, operative records or labeled/sequential xrays were provided for review.Based solely on the pi report, implant sheets and unlabeled xrays.It appears a left tha was performed with an insignia stem.A periprosthetic fracture occurred either intraoperatively and was unrecognized, or an event occurred in the immediate post-operative period that created a periprosthetic fracture.The femoral stem was revised to a restoration modular and rif or the fracture fragment with dale-miles cables.No postoperative data was provided for review.Event confirmation: assuming the x-rays which were undated and unlabeled are in fact associated with the pi report, a periprosthetic fracture around an insignia stem with revision to a restoration modular stem with dall-miles cables can be confirmed.The events causing the fracture cannot be confirmed.Root cause: the root cause of the revision was periprosthetic femur fracture.The cause of the fracture cannot be ascertained with the data provided." -product history review: review of the product history records indicate the reported device was manufactured with no reported relevant 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.A review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical data, history, operative records or labeled/sequential xrays were provided for review.Based solely on the pi report, implant sheets and unlabeled xrays.It appears a left tha was performed with an insignia stem.A periprosthetic fracture occurred either intraoperatively and was unrecognized, or an event occurred in the immediate post-operative period that created a periprosthetic fracture.The femoral stem was revised to a restoration modular and rif or the fracture fragment with dale-miles cables.No postoperative data was provided for review.Event confirmation: assuming the x-rays which were undated and unlabeled are in fact associated with the pi report, a periprosthetic fracture around an insignia stem with revision to a restoration modular stem with dall-miles cables can be confirmed.The events causing the fracture cannot be confirmed.Root cause: the root cause of the revision was periprosthetic femur fracture.The cause of the fracture cannot be ascertained with the data provided." 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.

• 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: juana hiciano ; raheen business park; limerick, NJ NA ; EI NA ; +353 2018315000
• MDR Report Key: 24362421
• Report Number: 0002249697-2026-00099
• Device Sequence Number: 17381645
• Product Code: JDI
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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: 7000-6603
• Device Lot Number: 35842051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2025
• 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; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female