MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT HFX HIP STEM SIZE #08 127; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6076-0830A

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 05/02/2023

Event Type  Injury  

Event Description

It was reported that the patient's right hip was revised due to pain.Surgeon's original plan was to convert the patient's hemi hip to a total hip by revising the unipolar component.However, when he tapped on the component, the stem came out of the patient's femur.All components were revised with stryker acetabular components and competitor femoral components.

Manufacturer Narrative

Reported event: an event regarding loosening involving an omnifit stem was reported.The event was not confirmed.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 and tissue visible on the trunnion and stem neck.The device appears otherwise unremarkable.Clinician review: a review of medical records with a clinical consultant indicated " this patient underwent revision surgery for a painful right hip arthroplasty.At the time it was felt that the pain was due to the unipolar replacement of the acetabulum but at the time of surgery the femoral component was found to be loose.I can confirm that the patient had a right hip arthroplasty but i have no other information to confirm the revision.The root causes of pain from a unipolar hip arthroplasty and loose femoral stem are multifactorial including surgical technique, especially achieving stable and satisfactory initial fixation, patient factors including bmi, activity level and quality of acetabular bone especially if arthritic change was already present or secondarily developed.Nothing in the history provided would suggest 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: it was reported that during conversion surgery from hemi to total, intraoperatively, the stem was observed to have loosened.The reported devices were not returned however photographs were provided for review.The photographs show a recently explanted stem with blood and tissue visible on the trunnion and stem neck.The stem appears otherwise unremarkable.A review of medical records with a clinical consultant indicated " this patient underwent revision surgery for a painful right hip arthroplasty.At the time it was felt that the pain was due to the unipolar replacement of the acetabulum but at the time of surgery the femoral component was found to be loose.I can confirm that the patient had a right hip arthroplasty but i have no other information to confirm the revision since i have no office notes or operation reports for postoperative radiographs.The root causes of pain from a unipolar hip arthroplasty and loose femoral stem are multifactorial including surgical technique, especially achieving stable and satisfactory initial fixation, patient factors including bmi, activity level and quality of acetabular bone especially if arthritic change was already present or secondarily developed.Nothing in the history provided would suggest any causality to the implant itself." the exact cause of the event could not be determined.Further information such as office notes, pre- and post-operative x-rays and the revision 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: device name#unitrax c-taper sleeve +0mm ; cat#6942-7-065 ; lot#86473801.Device name#unitrax modular endo head 48mm ; cat#6942-5-048 ; lot#7a1jta.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device not returned to the manufacturer.

• Brand Name: OMNIFIT HFX HIP STEM SIZE #08 127
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17011849
• MDR Text Key: 316100648
• Report Number: 0002249697-2023-00589
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327023572
• UDI-Public: 07613327023572
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031744
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2023

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
• Device Operator: Health Professional
• Device Model Number: 6076-0830A
• Device Catalogue Number: 6076-0830A
• Device Lot Number: LV4W34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 64 KG