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	Fracture (1260); Unstable (1667); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "revision for pain and instability of right total hip.Patient reported index total hip over 10 years ago.X-ray demonstrates partial dissociation from femoral stem.Operative findings included metallosis with associated soft tissue staining.Damaged trunnion of the femoral stem was noted.The stem was well fixed.It was explanted using high speed bur and use of flexible osteotomes.Femur was prepared and implanted with a revision femoral prosthesis from another manufacturer.".
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 other similar events for the lot referenced.Device not returned to the manufacturer.
Event or Problem Description
As reported: "revision for pain and instability of right total hip.Patient reported index total hip over 10 years ago.X-ray demonstrates partial dissociation from femoral stem.Operative findings included metallosis with associated soft tissue staining.Damaged trunnion of the femoral stem was noted.The stem was well fixed.It was explanted using high speed bur and use of flexible osteotomes.Femur was prepared and implanted with a revision femoral prosthesis from another manufacturer.".
Additional Manufacturer Narrative
Reported event an event regarding disassociation involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was confirmed through photographs/clinician review.Method & results -product evaluation and results: no product was returned for evaluation however, photographs were provided for review.The photographs show a recently explanted stem and head.Blood is visible on both devices with bony ingrowth also visible on the stem.The trunnion of the stem appears damaged.-clinician review: a review of the provided medical records by a clinical consultant indicated: i can confirm that the hip failed due to disassociation since i was able to examine the x-rays.I cannot confirm that a revision occurred or the operative findings since i have no postoperative revision x-rays nor do i have an operation report or any office notes or documentation.I cannot determine the root cause with certainty.The root cause of femoral head disassociation, trunnionosis and metallosis are multifactorial including surgical technique factors, implant factors, patient factors such as activity level and bmi.This patient's bmi was elevated putting the patient in the obese category.Examination of the removed implants by stryker engineers would help in determining the root cause of this event.-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: a review of the provided medical records by a clinical consultant indicated: i can confirm that the hip failed due to disassociation since i was able to examine the x-rays.I cannot confirm that a revision occurred or the operative findings since i have no postoperative revision x-rays nor do i have an operation report or any office notes or documentation.I cannot determine the root cause with certainty.The root cause of femoral head disassociation, trunnionosis and metallosis are multifactorial including surgical technique factors, implant factors, patient factors such as activity level and bmi.This patient's bmi was elevated putting the patient in the obese category.Examination of the removed implants by stryker engineers would help in determining the root cause of this event.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.

• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 15188293
• Report Number: 0002249697-2022-01151
• Device Sequence Number: 17604012
• Product Code: LPH
• UDI-Device Identifier: 04546540510761
• UDI-Public: 04546540510761
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: 05/31/2011
• Device Model Number: 6021-4535
• Device Catalogue Number: 6021-4535
• Device Lot Number: 18230703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2006
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 98 KG