MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6720-0535
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374); Inadequate Osseointegration (2646); Periprosthetic fracture (4902)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The hip joint dislocated, and a revision was necessary.The patient had a uhr head and an accolade ii stem.Intraoperatively, it turned out that the head was not held on the stem, and the operator removed the head from the stem cone without any resistance.After removing the head and stem, stimulan was used because the patient had an infection.
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 similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
Corrected data: lot# an event regarding dislocation, periprosthetic fracture, loosening and infection involving a accolade stem was reported.The event of dislocation, loosening and periprosthetic fracture was confirmed via clinician review 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 information by a clinical consultant indicated: "the patient underwent unipolar arthroplasty for a transcervical neck fracture.This subsequently dislocated and was revised.At the time of the revision the stem was found to be grossly loose and the joint was infected.An incision and debridement was carried out along with explantation of the unipolar prosthesis.The root cause of this dislocation and infection cannot be determined from the documentation provided." 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.There have been no other similar events for the sterile lot referenced.Conclusions: all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.It was reported that the patient was revised due to dislocation and infection.A review of the provided medical information by a clinical consultant indicated: "the patient underwent unipolar arthroplasty for a transcervical neck fracture.This subsequently dislocated and was revised.At the time of the revision the stem was found to be grossly loose and the joint was infected.An incision and debridement was carried out along with explantation of the unipolar prosthesis.The root cause of this dislocation and infection cannot be determined from the documentation provided." 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: uhr bipolar 28x49mm; cat# uh1-49-28; lot# 864dat it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The hip joint dislocated, and a revision was necessary.The patient had a uhr head and an accolade ii stem.Intraoperatively, it turned out that the head was not held on the stem, and the operator removed the head from the stem cone without any resistance.After removing the head and stem, stimulant was used because the patient had an infection.
Additional Manufacturer Narrative
Corrected data: manufacturing date.An event regarding dislocation, periprosthetic fracture, loosening and infection involving an accolade stem was reported.The event of dislocation, loosening and periprosthetic fracture was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: visual inspection: damage consistent with explanation observed.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the patient underwent unipolar arthroplasty for a transcervical neck fracture.This subsequently dislocated and was revised.At the time of the revision the stem was found to be grossly loose and the joint was infected.An incision and debridement was carried out along with explantation of the unipolar prosthesis.The root cause of this dislocation and infection cannot be determined from the documentation provided." -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.There have been no other similar events for the sterile lot referenced.Conclusions: all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.It was reported that the patient was revised due to dislocation and infection.A review of the provided medical information by a clinical consultant indicated: "the patient underwent unipolar arthroplasty for a transcervical neck fracture.This subsequently dislocated and was revised.At the time of the revision the stem was found to be grossly loose and the joint was infected.An incision and debridement was carried out along with explantation of the unipolar prosthesis.The root cause of this dislocation and infection cannot be determined from the documentation provided." 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
No new information.

• Brand Name: SIZE 5 ACCOLADE II 132 DEG
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20155279
• Report Number: 0002249697-2024-01210
• Device Sequence Number: 8301144
• Product Code: LPH
• UDI-Device Identifier: 04546540664488
• UDI-Public: 04546540664488
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K103479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2025

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 Catalogue Number: 6720-0535
• Device Lot Number: 17803658A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 05/21/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 12/23/2024; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2024
• 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: 84 YR
• Patient Sex: Unknown