MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6721-0535

Device Problems Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)

Event Date 11/06/2023

Event Type  Injury  

Event Description

Patient's wife reported husband experiencing bursitis on right hip and may require a revision.Patient reported having surgery on the surrounding tissue but no implants were explanted.Patient would like to know if implants are subject to a recall.

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.H3 other text : device not returned to the manufacturer.

Event Description

Patient's wife reported husband experiencing bursitis on right hip and may require a revision.Patient reported having surgery on the surrounding tissue but no implants were explanted.Patient would like to know if implants are subject to a recall.Update: "is he has a tumor with fluid and metal shavings in it.Pretty scary that he needs to have another surgery for revision.".

Manufacturer Narrative

Reported event: an event regarding altr involving an unknown hip 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 requires revision for a tumor with fluid and metal shavings in it.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 primary/revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.The patient is also inquiring if their implants are subject to a recall.Device-identifying information such as catalog numbers and lot codes are required to perform a recall search.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.

Manufacturer Narrative

Reported event: an event regarding corrosion and abnormal ion level/altr involving an accolade stem was reported.The events were 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 information by a clinical consultant indicated: "the patient underwent an uncomplicated index tha on (b)(6) 2013.On (b)(6) 2023, this hip was revised with a head and liner exchange.The surgeon notes the reason for revision was increasing pain and increased serum metal ion levels.Intra-operatively the surgeon noted clear yellow fluid within the hip joint.Upon removing the head he noted minor black corrosive changes.The trunnion was noted to have no damage.Revision tha with head and liner exchange for increasing pain and elevated serum ion levels is conformed.The root cause of the pain and elevated ion levels cannot be determined from the limited documentation provided.[¿] the surgeon noted that the acetabular component was in "25 to 30degrees of anteversion".In most cases this is within the normal range of placement.He did not revise the metal acetabular shell to correct this anteversion.Instead, he revised the liner to a 10-degree lipped component.Although he notes that this is meant to "decrease the anteversion" in fact it does not change the anteversion of the cup.It increases coverage of the femoral head.No evidence was provided to confirm acetabular shell placement contributed to the patient's negative experience." product history review: review of the device history records indicate devices were manufactured and accepted into final stock on 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 corrosion at the head-stem junction and elevated metal ion levels.A review of the provided medical information by a clinical consultant indicated: a review of the provided medical information by a clinical consultant indicated: "the patient underwent an uncomplicated index tha on (b)(6) 2013.On (b)(6) 2023, this hip was revised with a head and liner exchange.The surgeon notes the reason for revision was increasing pain and increased serum metal ion levels.Intra-operatively the surgeon noted clear yellow fluid within the hip joint.Upon removing the head he noted minor black corrosive changes.The trunnion was noted to have no damage.Revision tha with head and liner exchange for increasing pain and elevated serum ion levels is conformed.The root cause of the pain and elevated ion levels cannot be determined from the limited documentation provided." it is further reported that the patient would like to know if their implants are subject to recall.A search indicated that the reported devices are not part of a recall.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 Description

Patient's wife reported husband experiencing bursitis on right hip and may require a revision.Patient reported having surgery on the surrounding tissue but no implants were explanted.Patient would like to know if implants are subject to a recall.Update: "is he has a tumor with fluid and metal shavings in it.Pretty scary that he needs to have another surgery for revision." update on 28-feb-2024: per revision op.Report, patient was revised on (b)(6) 2023.Update as per med review: the surgeon did note in the revision operative report that the shell was in 25 to 30 degrees of anteversion.A review of the provided medical records by a clinical consultant indicated: "the surgeon noted that the acetabular component was in "25 to 30degrees of anteversion".In most cases this is within the normal range of placement.He did not revise the metal acetabular shell to correct this anteversion.Instead, he revised the liner to a 10-degree lipped component.Although he notes that this is meant to "decrease the anteversion" in fact it does not change the anteversion of the cup.It increases coverage of the femoral head.No evidence was provided to confirm acetabular shell placement contributed to the patient's negative experience.".

• Brand Name: SIZE 5 ACCOLADE II 127 DEG
• Type of Device: 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 NJ NA ; EI NA
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18214442
• MDR Text Key: 329063077
• Report Number: 0002249697-2023-01462
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540669506
• UDI-Public: 04546540669506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 6721-0535
• Device Lot Number: 43311905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/06/2024; 04/29/2024
• Supplement Dates FDA Received: 01/29/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male