MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 2 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6721-0230
Medical Device Problem Codes	Degraded (1153); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient underwent left total hip arthroplasty on (b)(6) 2017.It is alleged that she began experiencing severe hip pain, burning pain when sitting and sleeping, along with clicking in the left hip.Radiographs showed aseptic loosening of the left femoral component.Workups completed revealed elevated metal levels (esr 38, crp 19, cobalt and chromium <1.0) and a left hip aspiration showed the growth of staph hominis.Allegedly as metallosis was suspected, she underwent a left total hip revision on (b)(6) 2020.
Additional Manufacturer Narrative
An event regarding loosening, abnormal ion level, wear and infection involving an accolade stem was reported.The event was not 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: no medical records were received for review with a clinical consultant.Product history review: review of the device history records 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 has been 1 other similar event for the sterile lot referenced.That event relates to infection.A review of both the sterilization data and microbiology data was performed for this sterile lot commonality.It was identified that the sterilization data was within specification and no microbiology excursions were noted for this lot and as such no further review is required.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.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports 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: cat# 1236-2-244; restoration adm x3 ins; lot# 333493.Cat# 626-00-38d; modular dual mobility insert; lot# 56571501.Cat# 542-11-48d; trident psl with purefix ha 48mm; lot# 57353004.Cat# 2060-0000-1; acetabular dome hole plug; lot# ml1emp.Cat# 2030-6530-1; 6.5 cancellous bone screw 30mm; lot# 903etw.Cat# 2030-6525-1; 6.5 cancellous bone screw 25mm; lot# 1e1j8nr.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: SIZE 2 ACCOLADE II 127 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18683761
• Report Number: 0002249697-2024-00213
• Device Sequence Number: 7243172
• Product Code: LPH
• UDI-Device Identifier: 04546540669476
• UDI-Public: 04546540669476
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2024

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: 10/31/2021
• Device Catalogue Number: 6721-0230
• Device Lot Number: 57217704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2016
• 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 Sex: Female