MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT HA HIP STEM #9; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Model Number 6017-0935A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032)

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding periprosthetic fracture involving an omnifit stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted stem with blood, tissue, and possibly bone adhered to the mid-distal portion.The metal head remains attached to the stem.No obvious damage is visible.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient ostensibly had a well-functioning right cementless total hip arthroplasty but then sustained a fracture of the femur below the tip of the stem.The patient already had a competitor total knee arthroplasty in place.An open reduction and internal fixation was carried out but this resulted in a nonunion with breakage of screws and pull away of the plate.The patient subsequently required a total femoral replacement and then sustained a dislocation of the hip which required insertion of a constrained liner.I can confirm that the patient had a primary right total hip arthroplasty and prior surgery with plate and screws which appears to be for a mid-shaft femoral fracture below the tip of the stem.I have only a single x-ray showing what i described.I have no documentation of further procedures regarding x-rays, office notes or operation notes.Causes of these events are multifactorial and the root causes cannot be determined with certainty.The patient did sustain a fall which resulted in a fracture of the femoral shaft below the tip of the stem.This would definitely be the cause of the fracture itself.Failure of fixation is multifactorial including surgical technique, patient bone quality issues, patient activity level and bmi.Screw breakage is not uncommon when internal fixation fails and in my opinion is not necessarily the fault of the screw but rather the technique of fixation and stability of the fracture.The cause of nonunion is also multifactorial including surgical technique, local bone factors and postoperative compliance with weight bearing, etc.I have no x-rays which would allow me to comment on the need for a total femoral prosthesis.The causes of dislocation a few days following hip arthroplasty are almost always iatrogenic meaning that there was most likely failure to restore the proper soft tissue tension to the thigh muscles and possibly impingement may have occurred.Without x-rays or other diagnostic tools, i cannot comment on the root cause of the dislocation with certainty." 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 has been 1 other similar event for the lot referenced.Conclusions: it was reported that the patient was revised due to non-union of the bone following a previous orif procedure to address a periprosthetic femoral fracture.A review of the provided medical information by a clinical consultant indicated the following: "this patient ostensibly had a well-functioning right cementless total hip arthroplasty but then sustained a fracture of the femur below the tip of the stem.The patient already had a competitor total knee arthroplasty in place.An open reduction and internal fixation was carried out but this resulted in a nonunion with breakage of screws and pull away of the plate.The patient subsequently required a total femoral replacement and then sustained a dislocation of the hip which required insertion of a constrained liner.I can confirm that the patient had a primary right total hip arthroplasty and prior surgery with plate and screws which appears to be for a mid-shaft femoral fracture below the tip of the stem.I have only a single x-ray showing what i described.I have no documentation of further procedures regarding x-rays, office notes or operation notes.Causes of these events are multifactorial and the root causes cannot be determined with certainty.The patient did sustain a fall which resulted in a fracture of the femoral shaft below the tip of the stem.This would definitely be the cause of the fracture itself.Failure of fixation is multifactorial including surgical technique, patient bone quality issues, patient activity level and bmi.Screw breakage is not uncommon when internal fixation fails and in my opinion is not necessarily the fault of the screw but rather the technique of fixation and stability of the fracture.The cause of nonunion is also multifactorial including surgical technique, local bone factors and postoperative compliance with weight bearing, etc.I have no x-rays which would allow me to comment on the need for a total femoral prosthesis." 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 Description

This pi is for the femoral stem and head.It was reported that the patient's right femur was revised.After a previous orif to address a femoral fracture, patient presented complaining of pain and limited rom.X-ray showed non-union of the bone with 3 broken screws and one screw which pulled out with the plate.A femoral stem and head, the plate and screws, and a competitor knee were revised to a competitor total femur replacement (acetabular components were left in situ).Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: OMNIFIT HA HIP STEM #9
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17084996
• MDR Text Key: 316802002
• Report Number: 0002249697-2023-00649
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07613327038279
• UDI-Public: 07613327038279
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2004
• Device Model Number: 6017-0935A
• Device Catalogue Number: 6017-0935A
• Device Lot Number: 46754903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/1999
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 84 KG