MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-0230

Device Problems Corroded (1131); Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

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

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

Review of the product history records indicate  devices were manufactured and accepted into final stock with no relevant reported discrepancies.  there have been no other events for the lot referenced.Device evaluation is anticipated but not yet begun.A supplemental report will be submitted upon completion of the investigation.

Event Description

As reported by rep: "doctor had a transferred patient come in on his service with a left leg with a femoral head disassociation.The patient was scheduled for surgery.The doctor's plan was to remove the stem, head and poly and hope to leave a well-fixed cup.When the doctor opened he noted metallosis.He removed the original accolade tmzf, lfit head and poly.He debrided and lavaged the area as well".Patient was revised to competitor stem, head, and a stryker liner.Rep provided a pre-revision x-ray and a sales order from the primary procedure.Rep reported he can obtain operative reports, and the explants for return.

Event Description

As reported by rep: "doctor had a transferred patient come in on his service with a left leg with a femoral head disassociation.The patient was scheduled for surgery.The doctor's plan was to remove the stem, head and poly and hope to leave a well-fixed cup.When the doctor opened he noted metallosis.He removed the original accolade tmzf, lfit head and poly.He debrided and lavaged the area as well".Patient was revised to competitor stem, head, and a stryker liner.Rep provided a pre-revision x-ray and a sales order from the primary procedure.Rep reported he can obtain operative reports, and the explants for return.

Manufacturer Narrative

Reported event: an event regarding disassociation & altr involving an accolade stem was reported.The disassociation was confirmed by medical review, however altr was not confirmed.Method & results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 05 aug 2019 this inspection indicated: the parts were examined with the aid of a stereo microscope at magnifications up to 50x.Biological material was observed on the stem.Damage and debris were observed on the trunnion of the stem.The damage is consistent with contact against the head taper and the explantation process.A sample of the debris was placed on a scanning electron microscope (sem) stub for further analysis.Dimensional & functional analysis: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original.Manufactured condition.A material analysis has been performed.The report concluded: damage and debris were observed on the stem trunnion, head taper, and insert.Scratching and burnishing were observed on the articulating surface of the insert.These are common damage modes of uhmwpe.Eds showed the stem was consistent with astm f1813 alloy, the head was consistent with astm f1537 alloy, the stem debris was consistent with the stem base alloy, biological material, corrosion product and an oxide.The head debris was consistent with a corrosion product, the stem base alloy, biological material and an oxide.The insert debris was consistent with the stem base alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms disassociation, need additional information; primary operative report, clinical and past medical history and examination of explanted components.Device history review: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including primary operative report, clinical and past medical history are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #2
• 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: 8747860
• MDR Text Key: 149629586
• Report Number: 0002249697-2019-02424
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510679
• UDI-Public: 04546540510679
• 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,other
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

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: 07/31/2009
• Device Catalogue Number: 6021-0230
• Device Lot Number: 9700903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR