MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 3 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6721-0330
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding altr/abnormal ion level, and corrosion involving a 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: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that patient was revised due to alleged altr/abnormal ion level and corrosion.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, 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.
Event or Problem Description
It was reported by patient's counsel as a result of a legal claim that the patient underwent right tha on (b)(6) 2013 and was implanted with an lfit v40 femoral head and accolade ii hip stem.Allegedly the patient developed lateral hip pain, high cobalt-chrome levels and mri was consistent with a large pseudotumor.The patient was revised on (b)(6) 2022 with a diagnosis of altr/taper corrosion.

• Brand Name: SIZE 3 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20182227
• Report Number: 0002249697-2024-01240
• Device Sequence Number: 8364318
• Product Code: LPH
• UDI-Device Identifier: 04546540669483
• UDI-Public: 04546540669483
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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 Catalogue Number: 6721-0330
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Female