MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6021-3535

Device Problems Degraded (1153); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient presented with a disassociated fem head.Upon review of the xrays, the surgeon determined that there was severe trunionosis.Revision surgery was performed.The head and stem were removed.We were able to implant a new accolade ii stem and biolox head.Right side.

Manufacturer Narrative

An event regarding disassociation and wear (trunnionosis) involving an accolade stem was reported.The event of wear was confirmed by evaluation of the returned device while disassociation was not confirmed.Method & results -product evaluation and results: the wear observed on the hip stem trunnion is consistent with loss of the taper lock between the stem trunnion and the femoral head.Eds showed the stem was consistent with an astm f1813 alloy.The material on the trunnion was consistent with an oxide/corrosion product and biological material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: evaluation of the retuned device revealed that the wear observed on the hip stem trunnion is consistent with loss of the taper lock between the stem trunnion and the femoral head.Eds showed the stem was consistent with an astm f1813 alloy.The material on the trunnion was consistent with an oxide/corrosion product and biological material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient presented with a disassociated fem head.Upon review of the xrays, the surgeon determined that there was severe trunionosis.Revision surgery was performed.The head and stem were removed.We were able to implant a new accolade ii stem and biolox head.Right side.

• Brand Name: ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10480280
• MDR Text Key: 205287447
• Report Number: 0002249697-2020-01783
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510754
• UDI-Public: 04546540510754
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

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: 06/30/2015
• Device Model Number: 6021-3535
• Device Catalogue Number: 6021-3535
• Device Lot Number: 33875202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 117