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

Model Number	7000-5505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	10/17/2022
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
Right total hip arthroplasty with a slightly displaced right greater trochanteric fracture after a fall diagnosed at post op visit on (b)(6) 2022.Patient opted for conservative management and re-evaluation in 2 weeks.Patient reports at follow up visit on (b)(6) 2022 her pain has increased slightly.Difficult to walk.Surgeon feels only option would be an orif w/possible head and liner exchange.(b)(6) 2022 surgeon performs orif and head and liner exchange.
Additional Manufacturer Narrative
D6b date of explant was populated in error in the initial emdr as the reported device was not explanted.An event regarding periprosthetic fracture involving an insignia stem was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection, dimensional, functional and material analysis could not be performed as the device remains implanted.Clinician review: a review of medical records with a clinical consultant indicated " this patient sustained a traumatic fracture of the greater trochanter within a week following her initial surgery.While i can confirm from office notes that the patient underwent the primary procedure and then sustained the fracture of the greater trochanter, i do not have the initial operation report or postoperative x-ray to examine.I can confirm that the patient underwent a second surgery to perform an open reduction and internal fixation of the fracture of the greater trochanter with exchange of her femoral head and acetabular liner since i was able to review the operation report.However i had no postoperative or follow-up x-rays to review.The root cause of this event cannot be determined with absolute certainty.The fracture of the greater trochanter which necessitated a repeat surgery most likely was precipitated by the fall sustained by the patient according to the summary provided.However, with no immediate postoperative i cannot be certain that there was not a fracture present that was exacerbated by the fall.With the information provided i would not assign any causality to the implant system.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 medical records with a clinical consultant indicated " this patient sustained a traumatic fracture of the greater trochanter within a week following her initial surgery.While i can confirm from office notes that the patient underwent the primary procedure and then sustained the fracture of the greater trochanter, i do not have the initial operation report or postoperative x-ray to examine.I can confirm that the patient underwent a second surgery to perform an open reduction and internal fixation of the fracture of the greater trochanter with exchange of her femoral head and acetabular liner since i was able to review the operation report.However i had no postoperative or follow-up x-rays to review.The root cause of this event cannot be determined with absolute certainty.The fracture of the greater trochanter which necessitated a repeat surgery most likely was precipitated by the fall sustained by the patient according to the summary provided.However, with no immediate postoperative i cannot be certain that there was not a fracture present that was exacerbated by the fall.With the information provided i would not assign any causality to the implant system.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
Right total hip arthroplasty with a slightly displaced right greater trochanteric fracture after a fall diagnosed at post op visit on (b)(6) 2022.Patient opted for conservative management and re-evaluation in 2 weeks.Patient reports at follow up visit on (b)(6) 2022 her pain has increased slightly.Difficult to walk.Surgeon feels only option would be an orif w/possible head and liner exchange.(b)(6) 2022 surgeon performs orif and head and liner exchange.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving an insignia stem was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection, dimensional, functional and material analysis could not be performed as the device remains implanted.-clinician review: a review of medical records with a clinical consultant indicated " this patient sustained a traumatic fracture of the greater trochanter within a week following her initial surgery.While i can confirm from office notes that the patient underwent the primary procedure and then sustained the fracture of the greater trochanter, i do not have the initial operation report or postoperative x-ray to examine.I can confirm that the patient underwent a second surgery to perform an open reduction and internal fixation of the fracture of the greater trochanter with exchange of her femoral head and acetabular liner since i was able to review the operation report.However i had no postoperative or follow-up x-rays to review.The root cause of this event cannot be determined with absolute certainty.The fracture of the greater trochanter which necessitated a repeat surgery most likely was precipitated by the fall sustained by the patient according to the summary provided.However, with no immediate postoperative i cannot be certain that there was not a fracture present that was exacerbated by the fall.With the information provided i would not assign any causality to the implant system.-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 medical records with a clinical consultant indicated " this patient sustained a traumatic fracture of the greater trochanter within a week following her initial surgery.While i can confirm from office notes that the patient underwent the primary procedure and then sustained the fracture of the greater trochanter, i do not have the initial operation report or postoperative x-ray to examine.I can confirm that the patient underwent a second surgery to perform an open reduction and internal fixation of the fracture of the greater trochanter with exchange of her femoral head and acetabular liner since i was able to review the operation report.However, i had no postoperative or follow-up x-rays to review.The root cause of this event cannot be determined with absolute certainty.The fracture of the greater trochanter which necessitated a repeat surgery most likely was precipitated by the fall sustained by the patient according to the summary provided.However, with no immediate postoperative i cannot be certain that there was not a fracture present that was exacerbated by the fall.With the information provided i would not assign any causality to the implant system.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: 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 15786479
• Report Number: 0002249697-2022-01613
• Device Sequence Number: 5471702
• Product Code: LPH
• UDI-Device Identifier: 07613327511604
• UDI-Public: 07613327511604
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K211703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2025

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 Model Number: 7000-5505
• Device Catalogue Number: 7000-5505
• Device Lot Number: 93274102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 01/06/2023; 05/23/2025
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 01/27/2023; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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
• Patient Weight: 59 KG