MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-2530
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The following devices were also listed in this report: unknown trident shell; cat# unknown; lot# unknown.Unknown liner; cat# unknown; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device remains implanted.
Event or Problem Description
As per the medical review: "the patient presented to her surgeon in (b)(6) 2022 with left groin and hip pain along with back pain.A bone scan was ordered along with labs.These were reviewed with patient in (b)(6) 2022.Elevated cobalt levels in a patient with bilateral press fit thas is confirmed.".
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level involving an accolade stem was reported.The event 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 remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: "index implantation of a press fit triathalon thas is confirmed.The laboratory results demonstrated an elevated esr at 37 and a normal crp at 6.9.Two separate results for serum cobalt levels were reviewed, one from (b)(6)2022 at 99 and the other from (b)(6)2023at 91.The mars mri showed fluid behind the right greater trochanter but no definitive evidence of pseudo tumor.The bone scan was negative." -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 the patient is experiencing pain and elevated metal ion levels.A review of the provided medical records by a clinical consultant confirmed elevated cobalt levels but was unable to determine 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.Correction: d6a.
Event or Problem Description
As per the medical review: "the patient presented to her surgeon in (b)(6)2022 with left groin and hip pain along with back pain.A bone scan was ordered along with labs.These were reviewed with patient in (b)(6)2022.Elevated cobalt levels in a patient with bilateral press fit thas is confirmed.".

• Brand Name: ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5
• 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: 18844247
• Report Number: 0002249697-2024-00346
• Device Sequence Number: 7861004
• Product Code: LPH
• UDI-Device Identifier: 04546540510747
• UDI-Public: 04546540510747
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K994366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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 Expiration Date: 02/29/2016
• Device Catalogue Number: 6021-2530
• Device Lot Number: 35994605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2011
• 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: Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 48 KG