MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-3535
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level involving an unknown 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 the patient was revised due to elevated metal ion levels.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.H3 other text : device not returned.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2016 and was revised on (b)(6) 2021.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.
Additional Manufacturer Narrative
Reported event: an event regarding altr and wear/metallosis 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: "event confirmation: a primary total hip can be confirmed and was performed in 2016 with placement of a cobalt chrome head and tmz f stem and a dall-miles cable for a small fracture.A revision hip arthroplasty can be confirmed in 2021.Increased metal levels can be confirmed as reported in the operative note, laboratory results were not provided in a report.Metal response can be confirmed.Device fall and injury cannot be confirmed.Root cause: the root cause of the primary hip arthroplasty was osteoarthritis.The root cause of the revision was pain and a reported metal response.The cause of the mental response was reported to be trunnionosis but contribution from the dall-miles cable cannot be excluded.The root cause of the increased metal levels was likely a trunnion response." -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 was revised due to elevated cobalt and chromium levels and altr due to metallic wear debris.A review of the provided medical records by a clinical consultant indicated: "event confirmation: a primary total hip can be confirmed and was performed in 2016 with placement of a cobalt chrome head and tmz f stem and a dall-miles cable for a small fracture.A revision hip arthroplasty can be confirmed in 2021.Increased metal levels can be confirmed as reported in the operative note, laboratory results were not provided in a report.Metal response can be confirmed.Device fall and injury cannot be confirmed.Root cause: the root cause of the primary hip arthroplasty was osteoarthritis.The root cause of the revision was pain and a reported metal response.The cause of the mental response was reported to be trunnionosis but contribution from the dall-miles cable cannot be excluded.The root cause of the increased metal levels was likely a trunnion response." 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 was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2016 and was revised on (b)(6) 2021.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.Update: per medical records received: pain, osteolysis, altr due to metallic wear debris, and bone deficiency around the stem were also reported.The head and liner were revised.The polyethylene liner was observed to have worn in a symmetric fashion.The dall-miles cable was removed and unneeded.It was loose and abrading the proximal portion of the stem slightly.Repair of the abductor muscle tear was performed as well as a bone graft and cement to address the thin cortical bone around the stem.The stem was well-fixed and not revised.The trunnion was in usable condition with mild visible burnishing and corrosion damage.

• Brand Name: ACCOLADE 132 SIZE 3.5
• 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: 17076242
• Report Number: 0002249697-2023-00641
• Device Sequence Number: 6243912
• Product Code: LPH
• UDI-Device Identifier: 04546540510624
• UDI-Public: 04546540510624
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: 11/30/2020
• Device Catalogue Number: 6020-3535
• Device Lot Number: 53508103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2015
• 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: 70 YR
• Patient Sex: Female