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

Model Number	7000-6606
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	08/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "diagnosis: right hip pain.Right hip revision arthroplasty femoral component only with open reduction internal fixation.No further information available per hospital." a stem and head were revised.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
An event regarding periprosthetic 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 was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry concerns a 61-year-old female who underwent a total hip arthroplasty and in the immediate postoperative period suffered a periprosthetic fracture.This occurred sometime between the index procedure and 12 days later when the revision procedure took place.I can confirm that a periprosthetic fracture occurred since i was able to see the x-rays showing the fracture.I can infer from the usage sheets and the narrative that the patient did undergo a revision procedure but i have no direct documentation such as office notes or operation reports or post-revision x-rays.The root cause of this event cannot be determined for certain.However, the cause of periprosthetic fracture in the immediate postoperative period, in the absence of trauma, is almost always surgical technique related.An operation note of the primary procedure would be helpful.If the procedure was done through a direct anterior approach, it is not uncommon to see periprosthetic fractures.In addition, based on comparing the size of the implant to the patient's proximal femoral anatomy, i do get the feeling that the implant was too large for the patient and that it is possible that an unrecognized fracture occurred during the time of broaching and or insertion.Another cause of periprosthetic fracture could be trauma, but no one was reported.I see no causality related 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
As reported: "diagnosis: right hip pain.Right hip revision arthroplasty femoral component only with open reduction internal fixation.No further information available per hospital." a stem and head were revised.

• Brand Name: HIGH 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15318317
• Report Number: 0002249697-2022-01266
• Device Sequence Number: 17509618
• Product Code: JDI
• UDI-Device Identifier: 07613327511406
• UDI-Public: 07613327511406
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 12/02/2022

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: 7000-6606
• Device Catalogue Number: 7000-6606
• Device Lot Number: 91026101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 98 KG