MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6721-0435
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the "patient underwent revision surgery to remove stem/head/poly from trident/accolade total hip.Exhibited pseudo tumor and evidence of trunnionosis".
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 wear/trunnionosis, corrosion, and altr involving a accolade stem was reported.The wear/trunnionosis and corrosion events were confirmed via evaluation of the returned device.Altr was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device was performed as part of the material analysis: material analysis: a material analysis was performed and concluded the following: "review of size 4 accolade ii 127 deg, catalogue # 6721-0435, lot code 55927503, v40 cocr lfit head 36mm/+5, catalogue # 6260-9-236, lot code 7w60ya and liner was completed for evidence of wear of the femoral head-neck interface.Characterisation using stereo microscopy confirmed material wear of the stem trunnion and within the head taper of the lfit head.Energy dispersive spectroscopy confirmed oxidation of the accolade ii stem and lfit head in the discoloured regions, indicating corrosion.No manufacturing related defects were observed on the examined areas of the components." -clinician review: no medical records were received for review with a clinical consultant.-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 pseudotumor and trunnionosis.Visual inspection of the returned device was performed as part of the material analysis: the material analysis concluded the following: "review of size 4 accolade ii 127 deg, catalogue # 6721-0435, lot code 55927503, v40 cocr lfit head 36mm/+5, catalogue # 6260-9-236, lot code 7w60ya and liner was completed for evidence of wear of the femoral head-neck interface.Characterisation using stereo microscopy confirmed material wear of the stem trunnion and within the head taper of the lfit head.Energy dispersive spectroscopy confirmed oxidation of the accolade ii stem and lfit head in the discoloured regions, indicating corrosion.No manufacturing related defects were observed on the examined areas of the components." additional information such as medical records is required to confirm pseudotumor/altr in the patient.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.
Event or Problem Description
It was reported that the "patient underwent revision surgery to remove stem/head/poly from trident/accolade total hip.Exhibited pseudo tumor and evidence of trunnionosis".

• Brand Name: SIZE 4 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15090311
• Report Number: 0002249697-2022-01070
• Device Sequence Number: 20124068
• Product Code: LPH
• UDI-Device Identifier: 04546540669490
• UDI-Public: 04546540669490
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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: 06/30/2021
• Device Model Number: 6721-0435
• Device Catalogue Number: 6721-0435
• Device Lot Number: 55927503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 07/23/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2016
• 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 Sex: Unknown