MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 41MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6942-5-041
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left hip was converted from a hemi to a total hip due to the modular endo head migrating through the acetabulum.Intra-operatively, metal staining was noted at the junction of the stem and sleeve, and some metal staining in the surrounding tissue.
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.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.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving an other hip head was reported.The event was confirmed.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 medical records with a clinical consultant indicated "this patient underwent a left hip hemi arthroplasty and then 6 1/2 years later required revision surgery for protrusio of the femoral head through the acetabulum.I can confirm that the patient had protrusio but i cannot confirm that revision was indeed carried out since i have no postoperative x-ray nor do i have any operation reports.The surgeon apparently found a metal staining around the implant and the soft tissues but i cannot confirm this as i have no documentation for this except in the summary.The root cause of protrusio following a hemi arthroplasty is multifactorial.When the patient undergoes a hemi arthroplasty because there is no acetabular component, the metal head can wear against whatever acetabular cartilage is left and gradually move medially.This especially can occur in patients who are osteopenic.The patient's bmi and activity level can also contribute as well as trauma.The root cause of metal staining around and implant and in the soft tissue is also multifactorial including surgical technique factors, patient factors including bmi and activity level and implant factors.".Product history review: review of the device history records indicate the 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 the modular endo head migrated through the acetabulum.A review of medical records with a clinical consultant indicated "this patient underwent a left hip hemi arthroplasty and then 6 1/2 years later required revision surgery for protrusio of the femoral head through the acetabulum.I can confirm that the patient had protrusio but i cannot confirm that revision was indeed carried out since i have no postoperative x-ray nor do i have any operation reports.The surgeon apparently found a metal staining around the implant and the soft tissues but i cannot confirm this as i have no documentation for this except in the summary.The root cause of protrusio following a hemi arthroplasty is multifactorial.When the patient undergoes a hemi arthroplasty because there is no acetabular component, the metal head can wear against whatever acetabular cartilage is left and gradually move medially.This especially can occur in patients who are osteopenic.The patient's bmi and activity level can also contribute as well as trauma.The root cause of metal staining around and implant and in the soft tissue is also multifactorial including surgical technique factors, patient factors including bmi and activity level and implant factors.".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
It was reported that the patient's left hip was converted from a hemi to a total hip due to the modular endo head migrating through the acetabulum.Intra-operatively, metal staining was noted at the junction of the stem and sleeve, and some metal staining in the surrounding tissue.

• Brand Name: UNITRAX MODULAR ENDO HEAD 41MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15266693
• Report Number: 0002249697-2022-01204
• Device Sequence Number: 6475997
• Product Code: JDI
• UDI-Device Identifier: 07613327032352
• UDI-Public: 07613327032352
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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 Expiration Date: 03/31/2020
• Device Model Number: 6942-5-041
• Device Catalogue Number: 6942-5-041
• Device Lot Number: PM80TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2015
• 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: 82 YR
• Patient Sex: Female