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

Model Number	6021-2530
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	12/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Right side hip revision, all components explanted were stryker components.The patient was re-implanted with new revision stryker components.The patient recently was reporting pain in her right hip, x-rays showed a disassociation and intraprosthetic dislocation of the femoral head from the trunnion of the stem.The patient¿s cobalt chrome levels were elevated and the stem/femoral head junction was failed, so the surgeon needed to revise the femoral component.There were adverse local tissue reactions surrounding the component, the femoral head had corrosion and severe wear was noted on the trunnion as the femoral head was fractured off.
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.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.Device not returned.
Event or Problem Description
Right side hip revision, all components explanted were stryker components.The patient was re-implanted with new revision stryker components.The patient recently was reporting pain in her right hip, x-rays showed a disassociation and intraprosthetic dislocation of the femoral head from the trunnion of the stem.The patient¿s cobalt chrome levels were elevated and the stem/femoral head junction was failed, so the surgeon needed to revise the femoral component.There were adverse local tissue reactions surrounding the component, the femoral head had corrosion and severe wear was noted on the trunnion as the femoral head was fractured off.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and altr/abnormal ion levels/corrosion involving an accolade stem was reported.The disassociation event was confirmed, but the altr/abnormal ion levels/corrosion event was not confirmed.Method & results: -product evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs indicated that the stem was recently explanted.The stem trunnion appears severely worn.Damage is consistent with loss of taper lock.-clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion of assessment: this inquiry reports the failure of a total hip replacement after over 15 years due to trunnion wear, elevated ion levels and disassociation.I can confirm that this event took place since i was able to see the explanted components.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnion wear and disassociation are multifactorial including surgical technique factors, patient factors and implant factors." -product history review: review of the device history records indicate the 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 disassociation of the head from the stem, altr, elevated ion levels, and corrosion at the head-stem junction.The disassociation event was confirmed through medical review and visual inspection of provided photographs of the devices.The altr/abnormal ion levels/corrosion event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the devices, pathology reports, the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.

• 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: 13314420
• Report Number: 0002249697-2022-00119
• Device Sequence Number: 17333621
• Product Code: LPH
• UDI-Device Identifier: 04546540510747
• UDI-Public: 04546540510747
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: 06/30/2010
• Device Model Number: 6021-2530
• Device Catalogue Number: 6021-2530
• Device Lot Number: 13671303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2021
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2005
• 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: 83 YR
• Patient Sex: Female