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

Catalog Number	7000-5503
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening 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: "i can confirm that the patient had an initial procedure on (b)(6) 2024 since i was able to see the original stryker stickers.I was also able to see x-rays before revision.I can confirm that another surgery occurred on (b)(6) 2025 since i was able to review an implant usage sheet with a stryker trident polyethylene insert.The root cause of this event cannot be determined with certainty.Causes of femoral loosening within four months after initial surgery are multifactorial including surgical technique, especially in the sizing of the implant and the assessment of stability of the implant.In my opinion the femoral stem appears somewhat undersized.While the quality of the bone could be implicated, in my opinion the bone quality appeared satisfactory and in fact the x-ray appearance could lead one to believe that there was another process going on such as infection since there is loss of the medial femoral cortex only four months following the surgery with a pedestal beneath the stem.Patient activity level, lifestyle and bmi can contribute.I would not assign any causality to the implant itself." 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 stem loosening.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had an initial procedure on (b)(6) 2024 since i was able to see the original stryker stickers.I was also able to see x-rays before revision.I can confirm that another surgery occurred on (b)(6) 2025 since i was able to review an implant usage sheet with a stryker trident polyethylene insert.The root cause of this event cannot be determined with certainty.Causes of femoral loosening within four months after initial surgery are multifactorial including surgical technique, especially in the sizing of the implant and the assessment of stability of the implant.In my opinion the femoral stem appears somewhat undersized.While the quality of the bone could be implicated, in my opinion the bone quality appeared satisfactory and in fact the x-ray appearance could lead one to believe that there was another process going on such as infection since there is loss of the medial femoral cortex only four months following the surgery with a pedestal beneath the stem.Patient activity level, lifestyle and bmi can contribute.I would not assign any causality to the implant itself." 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 revision was secondary to femoral loosening.The femur was removed and revised to a competitor revision stem and the insert was exchanged for a new 36mm insert.No further information available from doctor or hospital.

• Brand Name: STANDARD 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21642865
• Report Number: 0002249697-2025-00313
• Device Sequence Number: 7662310
• Product Code: LPH
• UDI-Device Identifier: 07613327511413
• UDI-Public: 07613327511413
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K211703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2025

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: 7000-5503
• Device Lot Number: 19807553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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: 75 YR
• Patient Sex: Female