MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-4535
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Distributor reported that "patient required a total revision of right hip.".
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
An event regarding disassociation involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was confirmed via evaluation of the returned devices.Method & results -product evaluation and results: product evaluation and results: visual inspection: visual inspection of the returned devices indicated that the trunnion of the stem is severely worn.The metal head has minor damage from explantation.Material analysis: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa.No further material analyses were performed.-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: the reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.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.
Event or Problem Description
Distributor reported that "patient required a total revision of right hip." update 11/15/2022: based on product inspection of the returned device, loss of taper lock was noted.
Event or Problem Description
Distributor reported that "patient required a total revision of right hip." update 11/15/2022: based on product inspection of the returned device, loss of taper lock was noted.(b)(6) 2023 - med review states: 'on (b)(6) 2022, the patient underwent a revision at which time black fluid and black staining of the hip was noted.The femoral head was loose on the trunnion and the trunnion was eroded.Elevated ion levels were present.The femoral stem was well fixed but there was bone loss present.It was decided to delay reconstruction and a spacer was implanted.'.
Additional Manufacturer Narrative
An event regarding disassociation, wear and abnormal ion levels involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was confirmed via evaluation of the returned devices and through a review of the provided medical records by a clinical consultant.Method & results -product evaluation and results: product evaluation and results: visual inspection: visual inspection of the returned devices indicated that the trunnion of the stem is severely worn.The metal head has minor damage from explantation.Material analysis: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa.No further material analyses were performed.-clinician review: a review of the provided medical records by a clinical consultant indicated: 'this patient underwent a right primary total hip replacement at some point in the past.He developed symptoms related to trunnion deformity with loosening of the femoral head with metallosis and bone loss with elevated metal ion levels.A two-stage revision was carried out initially to debride the hip, inserting a spacer and then at a second operation the hip was reconstructed.I can confirm that the first revision and the second revision occurred since i was able to review the operation reports.I cannot determine the root cause of this event with certainty.The causes of trunnionosis and metallosis elevated metal ion levels are multifactorial including surgical technique factors, patient activity level and bmi, and implant factors.The explanted prosthesis should be returned to stryker for examination and analysis by engineers.-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: the reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.Visual inspection of the returned devices indicated that the trunnion of the stem is severely worn.The metal head has minor damage from explantation.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 4.5 ACCOLADE (127 DEG) SIZE 4.5
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15630876
• Report Number: 0002249697-2022-01517
• Device Sequence Number: 20323709
• Product Code: LPH
• UDI-Device Identifier: 04546540510761
• UDI-Public: 04546540510761
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2023

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: 08/31/2015
• Device Model Number: 6021-4535
• Device Catalogue Number: 6021-4535
• Device Lot Number: 34391902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 11/15/2022; 07/03/2023
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 12/09/2022; 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2010
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male