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

Device Problems Degraded (1153); Material Erosion (1214); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Foreign Body Reaction (1868); Ambulation Difficulties (2544)

Event Date 10/25/2022

Event Type  Injury  

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.

Event Description

It was reported that the patient's left hip was revised due to trunnion wear and head dissociation.Intra-operatively, it was discovered the trunnion dug through the liner and was articulating against the shell, causing additional wear.Metallosis was also noted.The stem, head, and liner were revised.Rep can provide pictures, and confirmed that no further information will be released by the hospital or surgeon.

Event Description

It was reported that the patient's left hip was revised due to trunnion wear and head dissociation.Intra-operatively, it was discovered the trunnion dug through the liner and was articulating against the shell, causing additional wear.Metallosis was also noted.The stem, head, and liner were revised.Rep can provide pictures, and confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding disassociation involving an accolade stem that mated with a metal head and wear (metallosis) was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection of the returned devices indicated that the trunnion of the stem is severely worn.The metal head appears to have damage from the disassociation event and explantation.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: conclusion of assessment: trunnion wear leading to disarticulation of head from stem.Device or procedure related adverse event: disarticulation of head from stem with catastrophic trunnion wear.Root cause and confirmation: the root cause of the failure leading to need for revision was the trunnion wear and disarticulation of the head.The root cause of the trunnion wear cannot be defined without additional information.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 disassociation of the head from the stem and metallosis.The event was confirmed.The reported accolade stem was mated with an 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 required at this time.If additional information becomes 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
• Type of Device: 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: 15803531
• MDR Text Key: 303702876
• Report Number: 0002249697-2022-01640
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510761
• UDI-Public: 04546540510761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 6021-4535
• Device Catalogue Number: 6021-4535
• Device Lot Number: 35186103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male