MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6720-0535
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had an index right tha on (b)(6) 2021.Patient presented with right hip pain and squeaking.Patient underwent revision on (b)(6) 2022.Some corrosion was found on the taper-head union.All components were exchanged except the femoral stem.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion 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 information by a clinical consultant indicated: "the records confirm the patient underwent an uncomplicated primary right tha on (b)(6) 2021.Post-operatively the patient had ongoing pain unrelieved by conservative management.The patient did not have any instability issues and no obvious cause for this pain could be established.X-rays show a press fit tha in its normal position without evidence of loosening.She underwent a lidocaine challenge which temporarily relieved her pain.On (b)(6) 2022 she then underwent a revision of this tha with exchange of the cup, liner and head.In the operative note the surgeon describes some corrosion within the femoral head however the trunnion was not damaged and intact.There was evidence of liner wear posteriorly indicative of neck impingement.Because of this impingement the surgeon revised the cup to a more retroverted position to avoid this impingement.Post revision x-rays show the components to be in anatomic position.Revision of a primary tha for pain is confirmed.The root cause of the pain was related to cup malposition leading to impingement of the femoral neck." -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 pain and squeaking.Intraoperatively, corrosion at the stem-head junction was observed.Evidence of impingement posteriorly was also observed intraoperatively, so the acetabular component was revised to a more retroverted position.A review of the provided medical information by a clinical consultant indicated: "the records confirm the patient underwent an uncomplicated primary right tha on (b)(6) 2021.Post-operatively the patient had ongoing pain unrelieved by conservative management.The patient did not have any instability issues and no obvious cause for this pain could be established.X-rays show a press fit tha in its normal position without evidence of loosening.She underwent a lidocaine challenge which temporarily relieved her pain.On (b)(6) 2022 she then underwent a revision of this tha with exchange of the cup, liner and head.In the operative note the surgeon describes some corrosion within the femoral head however the trunnion was not damaged and intact.There was evidence of liner wear posteriorly indicative of neck impingement.Because of this impingement the surgeon revised the cup to a more retroverted position to avoid this impingement.Post revision x-rays show the components to be in anatomic position.Revision of a primary tha for pain is confirmed.The root cause of the pain was related to cup malposition leading to impingement of the femoral neck." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion 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 information by a clinical consultant indicated: "the records confirm the patient underwent an uncomplicated primary right tha on (b)(6) 2021.Post-operatively the patient had ongoing pain unrelieved by conservative management.The patient did not have any instability issues and no obvious cause for this pain could be established.X-rays show a press fit tha in its normal position without evidence of loosening.She underwent a lidocaine challenge which temporarily relieved her pain.On (b)(6) 2022 she then underwent a revision of this tha with exchange of the cup, liner and head.In the operative note the surgeon describes some corrosion within the femoral head however the trunnion was not damaged and intact.There was evidence of liner wear posteriorly indicative of neck impingement.Because of this impingement the surgeon revised the cup to a more retroverted position to avoid this impingement.Post revision x-rays show the components to be in anatomic position.Revision of a primary tha for pain is confirmed.The root cause of the pain was related to cup malposition leading to impingement of the femoral neck." 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 pain and squeaking.Intraoperatively, corrosion at the stem-head junction was observed.Evidence of impingement posteriorly was also observed intraoperatively, so the acetabular component was revised to a more retroverted position.A review of the provided medical information by a clinical consultant indicated: "the records confirm the patient underwent an uncomplicated primary right tha on (b)(6) 2021.Post-operatively the patient had ongoing pain unrelieved by conservative management.The patient did not have any instability issues and no obvious cause for this pain could be established.X-rays show a press fit tha in its normal position without evidence of loosening.She underwent a lidocaine challenge which temporarily relieved her pain.On (b)(6) 2022 she then underwent a revision of this tha with exchange of the cup, liner and head.In the operative note the surgeon describes some corrosion within the femoral head however the trunnion was not damaged and intact.There was evidence of liner wear posteriorly indicative of neck impingement.Because of this impingement the surgeon revised the cup to a more retroverted position to avoid this impingement.Post revision x-rays show the components to be in anatomic position.Revision of a primary tha for pain is confirmed.The root cause of the pain was related to cup malposition leading to impingement of the femoral neck." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text : not available.
Event or Problem Description
Patient had an index right tha on (b)(6) 2021.Patient presented with right hip pain and squeaking.Patient underwent revision on (b)(6) 2022.Some corrosion was found on the taper-head union.All components were exchanged except the femoral stem.

• Brand Name: SIZE 5 ACCOLADE II 132 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18035814
• Report Number: 0002249697-2023-01286
• Device Sequence Number: 20932225
• Product Code: LPH
• UDI-Device Identifier: 04546540664488
• UDI-Public: 04546540664488
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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: 04/30/2026
• Device Catalogue Number: 6720-0535
• Device Lot Number: 84699604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2021
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 99 KG