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

Catalog Number	7000-5508
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: patient complaining of loosening of femoral component.Surgeon opted to explant insignia stem, and femoral head, and replace with a restoration modular revision stem, and new ceramic femoral head.
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
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving an insignia stem was reported.The event was not confirmed.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 cannot appreciate any radiolucencies about the primary insignia stem.The restoration modular stem is in anatomic position with pristine interfaces.Loss of fixation and failure of this femoral stem cannot be confirmed from the information 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 stem loosening.A review of the provided medical records by a clinical consultant indicated: "i cannot appreciate any radiolucencies about the primary insignia stem.The restoration modular stem is in anatomic position with pristine interfaces.Loss of fixation and failure of this femoral stem cannot be confirmed from the information 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: STANDARD 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 23300796
• Report Number: 0002249697-2025-01076
• Device Sequence Number: 10027835
• Product Code: JDI
• UDI-Device Identifier: 07613327511550
• UDI-Public: 07613327511550
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: 7000-5508
• Device Lot Number: 14069153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White