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 Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: subject was under investigation for back pain (not related to hip implant): blood sample showed elevated cobalt and right hip prosthesis shows wearing (subject has no symptoms).
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.H3 other text : device not returned.
Event or Problem Description
The following was reported: subject was under investigation for back pain (not related to hip implant): blood sample showed elevated cobalt and right hip prosthesis shows wearing (subject has no symptoms).
Additional Manufacturer Narrative
Reported event: an event regarding altr/abnormal ion level and wear involving an accolade stem was reported.The event for abnormal ion level was confirmed.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: "the patient presented to her surgeon on (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 on (b)(6) 2022.The bone scan did not show any evidence of loosening or infection.Serum labs showed an esr of 37, crp 0f 6.9 and elevated cobalt level of 93.8.Because of the elevated cobalt level, a mars mri was ordered.These results were reviewed in january 2023.The mri was essentially normal on the painful left side, however there was a posterior fluid collection around the asymptomatic right hip questionable for pseudotumor.Patient was referred to a spine surgeon for evaluation.Last reported visit for this patient was on (b)(6) 2023.At that time her right hip remained asymptomatic.In the interim she had received two injections in her spine which somewhat alleviated her left groin pain.In his notes from this visit the surgeon notes that her repeated labs showed her cobalt levels had "dropped.The patient was referred back to spine.Elevated cobalt levels in a patient with bilateral press fit thas is confirmed.The clinical significance of this is questionable.The root cause of this elevated serum metal ion level cannot be determined from the information provided.Should additional information become available i would be happy to further this assessment." 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 blood sample showed elevated cobalt and right hip prosthesis shows wearing.A review of the provided medical records by a clinical consultant indicated: "the patient presented to her surgeon on (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 on (b)(6) 2022.The bone scan did not show any evidence of loosening or infection.Serum labs showed an esr of 37, crp 0f 6.9 and elevated cobalt level of 93.8.Because of the elevated cobalt level, a mars mri was ordered.These results were reviewed in january 2023.The mri was essentially normal on the painful left side, however there was a posterior fluid collection around the asymptomatic right hip questionable for pseudotumor.Patient was referred to a spine surgeon for evaluation.Last reported visit for this patient was on (b)(6) 2023.At that time her right hip remained asymptomatic.In the interim she had received two injections in her spine which somewhat alleviated her left groin pain.In his notes from this visit the surgeon notes that her repeated labs showed her cobalt levels had "dropped.The patient was referred back to spine.Elevated cobalt levels in a patient with bilateral press fit thas is confirmed.The clinical significance of this is questionable.The root cause of this elevated serum metal ion level cannot be determined from the information provided.Should additional information become available i would be happy to further this assessment." no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17988930
• Report Number: 0002249697-2023-01245
• Device Sequence Number: 12829100
• Product Code: LPH
• UDI-Device Identifier: 04546540510747
• UDI-Public: 04546540510747
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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: 01/31/2018
• Device Catalogue Number: 6021-2530
• Device Lot Number: 42326503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2013
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 48 KG