MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6721-0635
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient underwent right tha on (b)(6) 2014, and was implanted with an lfit anatomic cocr v40 femoral head and an accolade ii hip stem and was revised on (b)(6) 2024.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.
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.
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level & corrosion involving a accolade stem was reported.The event was confirmed via medical review.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 records by a clinical consultant indicated: "i can confirm that the patient underwent a primary total hip arthroplasty on (b)(6) 2014, a second procedure on (b)(6) 2014 for evacuation of the hematoma and debridement, and a revision on (b)(6) 2024 due to trunnion corrosion and elevated metal ion levels.I was able to review the operation reports for all procedures.Root cause analysis: the root cause of these events cannot be determined with certainty.The root cause of hematoma formation is multifactorial including inadequate closure, inadequate hemostasis, possible trauma, and possible bleeding disorder of the patient.The root causes of trunnion corrosion and elevated metal ion levels are also multifactorial including surgical technique especially in the way the trunnion and femoral head is prepared prior to insertion.No mention was made of any particular preparation in this case.Patient activity level, lifestyle and bmi can also be a factor as well as implant factors." product history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to abnormal ion level.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient underwent a primary total hip arthroplasty on (b)(6) 2014, a second procedure on april 3, 2014 for evacuation of the hematoma and debridement, and a revision on (b)(6) 2024 due to trunnion corrosion and elevated metal ion levels.I was able to review the operation reports for all procedures.Root cause analysis: the root cause of these events cannot be determined with certainty.The root cause of hematoma formation is multifactorial including inadequate closure, inadequate hemostasis, possible trauma, and possible bleeding disorder of the patient.The root causes of trunnion corrosion and elevated metal ion levels are also multifactorial including surgical technique especially in the way the trunnion and femoral head is prepared prior to insertion.No mention was made of any particular preparation in this case.Patient activity level, lifestyle and bmi can also be a factor as well as 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 through the filing of a lawsuit that allegedly the patient underwent right tha on (b)(6) 2014, and was implanted with an lfit anatomic cocr v40 femoral head and an accolade ii hip stem and was revised on (b)(6) 2024.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.

• Brand Name: SIZE 6 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 19449058
• Report Number: 0002249697-2024-00823
• Device Sequence Number: 3214229
• Product Code: LPH
• UDI-Device Identifier: 04546540669513
• UDI-Public: 04546540669513
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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 Expiration Date: 12/31/2018
• Device Catalogue Number: 6721-0635
• Device Lot Number: 46144002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2013
• 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: 68 YR
• Patient Sex: Male