MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-3535
Medical Device Problem Codes	Degraded (1153); Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
The following was reported: "the patient bent over and it cracked in his left hip.You can see the broken cone." update: proposed revision date is set for (b)(6) 2025.Update: the customer told me that the neck is not broken.The metal shows a high degree of abrasion.
Additional Manufacturer Narrative
Reported event: an event regarding fracture involving a accolade stem was reported.The event was confirmed via medical review.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: there is no patient history, medical records or sequential x-rays provided for review.Revision data was not provided for review.The pi report notes a crack occurring in the "cone" of the hip stem when the patient bent over.The primary operative report shows placement of a tmzf stem with a lfit v40 metal head.Unlabeled/undated x-rays show disarticulation of the femoral head from the stem and likely fracture/severe trunnion wear.A revision surgery is not documented but alluded to and would be expected.Event confirmation: disarticulation of an lfit v40 metal femoral head from a tmzf stem can be confirmed.Fracture of the stem and/or severe trunnion wear is noted.Revision cannot be confirmed but would be expected.Root cause: the root cause of the proposed revision would be disarticulation of the lfit v40 metal femoral head from the tmzf stem.The root cause of the disarticulation of the head would be either fracture/severe trunnion wear.The root cause for the fracture/severe trunnionosis cannot be stated." -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 trunnion wear/fracture.A review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: there is no patient history, medical records or sequential x-rays provided for review.Revision data was not provided for review.The pi report notes a crack occurring in the "cone" of the hip stem when the patient bent over.The primary operative report shows placement of a tmzf stem with a lfit v40 metal head.Unlabeled/undated x-rays show disarticulation of the femoral head from the stem and likely fracture/severe trunnion wear.A revision surgery is not documented but alluded to and would be expected.Event confirmation: disarticulation of an lfit v40 metal femoral head from a tmzf stem can be confirmed.Fracture of the stem and/or severe trunnion wear is noted.Revision cannot be confirmed but would be expected.Root cause: the root cause of the proposed revision would be disarticulation of the lfit v40 metal femoral head from the tmzf stem.The root cause of the disarticulation of the head would be either fracture/severe trunnion wear.The root cause for the fracture/severe trunnionosis cannot be stated." 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.
Event or Problem Description
The following was reported: "the patient bent over and it cracked in his left hip.You can see the broken cone." update: proposed revision date is set for (b)(6)2025.Update: the customer told me that the neck is not broken.The metal shows a high degree of abrasion.
Additional Manufacturer Narrative
Reported event: an event regarding wear and disassociation involving a accolade stem was reported.The event was confirmed via medical review.Method & results: product evaluation and results: visual inspection & material analysis: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.The trunnion of the stem is severely worn.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: there is no patient history, medical records or sequential x-rays provided for review.Revision data was not provided for review.The pi report notes a crack occurring in the "cone" of the hip stem when the patient bent over.The primary operative report shows placement of a tmzf stem with a lfit v40 metal head.Unlabeled/undated x-rays show disarticulation of the femoral head from the stem and likely fracture/severe trunnion wear.A revision surgery is not documented but alluded to and would be expected.Event confirmation: disarticulation of an lfit v40 metal femoral head from a tmzf stem can be confirmed.Fracture of the stem and/or severe trunnion wear is noted.Revision cannot be confirmed but would be expected.Root cause: the root cause of the proposed revision would be disarticulation of the lfit v40 metal femoral head from the tmzf stem.The root cause of the disarticulation of the head would be either fracture/severe trunnion wear.The root cause for the fracture/severe trunnionosis cannot be stated." 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 trunnion wear/fracture.A review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: there is no patient history, medical records or sequential x-rays provided for review.Revision data was not provided for review.The pi report notes a crack occurring in the "cone" of the hip stem when the patient bent over.The primary operative report shows placement of a tmzf stem with a lfit v40 metal head.Unlabeled/undated x-rays show disarticulation of the femoral head from the stem and likely fracture/severe trunnion wear.A revision surgery is not documented but alluded to and would be expected.Event confirmation: disarticulation of an lfit v40 metal femoral head from a tmzf stem can be confirmed.Fracture of the stem and/or severe trunnion wear is noted.Revision cannot be confirmed but would be expected.Root cause: the root cause of the proposed revision would be disarticulation of the lfit v40 metal femoral head from the tmzf stem.The root cause of the disarticulation of the head would be either fracture/severe trunnion wear.The root cause for the fracture/severe trunnionosis cannot be stated." visual inspection & material analysis: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.The trunnion of the stem is severely worn.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
No new information.

• Brand Name: ACCOLADE 132 SIZE 3.5
• 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: 21343414
• Report Number: 0002249697-2025-00185
• Device Sequence Number: 9116365
• Product Code: LPH
• UDI-Device Identifier: 04546540510624
• UDI-Public: 04546540510624
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2025

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: 04/30/2016
• Device Catalogue Number: 6020-3535
• Device Lot Number: 36274506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 02/10/2025; 07/08/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/06/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2011
• 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: 70 YR
• Patient Sex: Male