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

Catalog Number	7000-6606
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
The following was reported: "left hip.Patient revised due to periprosthetic fracture.No other information available due to hospital policy.".
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving an insignia stem was reported.The event was confirmed via clinician review of medical records.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: confirmation of event: i can confirm that this patient sustained a periprosthetic fracture since i was able to see an x-ray showing the pathology.Root cause analysis: the root cause of this event cannot be determined with certainty with the information provided.The root causes of periprosthetic fractures 18 days or earlier after primary surgery are multifactorial.If the patient was doing well and then had a documented fall, then the cause would be due to trauma.If there is no history of any trauma or untoward event, then the cause would be iatrogenic, meaning that there must have been a breach of the cortex either recognized or unrecognized.I cannot know for sure because i do not have the primary operation report.I would have to see the original preoperative x-rays with preoperative templating to see if the proper size implant was utilized.In many cases, the surgeon may attempt to put in a somewhat large, larger implant that is compatible with the patient¿s anatomy.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.A review of the provided medical records by a clinical consultant indicated: 'confirmation of event: i can confirm that this patient sustained a periprosthetic fracture since i was able to see an x-ray showing the pathology.Root cause analysis: the root cause of this event cannot be determined with certainty with the information provided.The root causes of periprosthetic fractures 18 days or earlier after primary surgery are multifactorial.If the patient was doing well and then had a documented fall, then the cause would be due to trauma.If there is no history of any trauma or untoward event, then the cause would be iatrogenic, meaning that there must have been a breach of the cortex either recognized or unrecognized.I cannot know for sure because i do not have the primary operation report.I would have to see the original preoperative x-rays with preoperative templating to see if the proper size implant was utilized.In many cases, the surgeon may attempt to put in a somewhat large, larger implant that is compatible with the patient¿s anatomy.' 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
No new information.

• Brand Name: HIGH INSIGNIA COLLARED HIP STEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 22144372
• Report Number: 0002249697-2025-00603
• Device Sequence Number: 18014111
• Product Code: LPH
• UDI-Device Identifier: 07613327511406
• UDI-Public: 07613327511406
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K211703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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 Catalogue Number: 7000-6606
• Device Lot Number: 28680554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/18/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• 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: 73 YR
• Patient Sex: Female