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

Model Number	7000-6602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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.Device implanted in patient.
Event or Problem Description
After insertion of the stem it was noted that the patient had a nondisplaced calcar fracture.We exposed the entirety of the fracture and it traveled to the lesser trochanter, but not into it or below it.We then removed the stem and placed two cables, one above the lesser trochanter and one below the lesser trochanter.The stem was reinserted and had excellent press-fit.
Additional Manufacturer Narrative
Reported event: an event regarding intraoperative fracture involving an other hip stem was reported.The event was confirmed via evaluation of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device remained implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: this case concerns a patient who underwent a primary cementless total hip arthroplasty that was complicated by a fracture of the calcar noted upon insertion of the final implant.The fracture was repaired with 2 dall miles cables.I can confirm that the procedure took place since i was able to review the operation report and the preoperative and postoperative x-rays.I can confirm that the fracture of the calcar occurred since it was noted in the operation report and the postop x-rays showed dall-miles cable fixation.The root cause of fracture of the calcar upon insertion of the implant is multifactorial but the primary cause would be surgical technique using an implant that was slightly too large or applying too much force upon insertion.A secondary factor would be the patient's bone structure.Patients who are osteopenic or osteoporotic are more prone to sustain fractures upon insertion.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: the event could not be confirmed as insufficient information was provided.Further information such as device return, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
After insertion of the stem it was noted that the patient had a nondisplaced calcar fracture.We exposed the entirety of the fracture and it traveled to the lesser trochanter, but not into it or below it.We then removed the stem and placed two cables, one above the lesser trochanter and one below the lesser trochanter.The stem was reinserted and had excellent press-fit.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16155681
• Report Number: 0002249697-2023-00037
• Device Sequence Number: 17905335
• Product Code: LPH
• UDI-Device Identifier: 07613327511543
• UDI-Public: 07613327511543
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K211703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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: 7000-6602
• Device Catalogue Number: 7000-6602
• Device Lot Number: 92339302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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: Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White