MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6020-0335

Device Problems Corroded (1131); Degraded (1153); Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Hip Fracture (2349); Osteolysis (2377); Reaction (2414); Metal Related Pathology (4530)

Event Date 07/21/2020

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.Device not returned.

Event Description

It was reported that the patient's left hip was revised due to metallosis and elevated metal ions.An lfit v40 head and poly liner were revised to a ceramic on poly bearing.Rep confirmed there are no allegations against the revised liner, and 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 metallosis and elevated metal ions.An lfit v40 head and poly liner were revised to a ceramic on poly bearing.Rep confirmed there are no allegations against the revised liner, and that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding abnormal ion level, altr, corrosion, periprosthetic fracture, metallosis and osteolysis involving an accolade stem was reported.The event was confirmed only for altr, corrosion, metallosis based on medical review.Method & results: -product evaluation and results: not performed as no items were returned.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment:(b)(6) 2020: stryker pi report (b)(6) 2013: implant sheet.Trident psl ha cluster shell 52-e, 25mm, 25mm, 20mm, screws 6.5 mm torx, 36-e 100 polyethylene liner, #3 accolade tmzf v40 1320 stem, lfit anatomic v40 36 +5mm head.(b)(6) 2020: operative note: revision left tha.Failed tha with metal taper corrosion, chronic displaced greater trochanteric fracture with extensive abductor necrosis and pseudotumor.Specimens sent to path including pseudotumor.Implants 52mm 00 polyethylene, 36mm +7.5 mm biolox ceramic head with titanium sleeve.Had metal levels and mri c/w metal taper corrosion, pseudotumor, osteolysis induced fracture of trochanter, chronic, and abductor necrosis from metallosis.Had cardiac procedure preop for optimization.Evidence of metallosis in joint and 70% of abductors involved.Osteolysis around the fractured troch.Extensive corrosion on the taper and head when removed.Cup and stem stable.Considered mdm and constraint but went with poly due to metallosis.Capsule and troch repaired with ethibond suture.Confirmation: revision surgery for metallosis and taper corrosion in the setting of an lfit v40 head and tmzf accolade stem could be confirmed.The increased metal levels could not be confirmed.Root cause: the root cause of the revision was trunnion corrosion and metallosis leading to abductor necrosis and pseudotumor.The root cause of the trunnion corrosion was likely a v40-lfit trunnion issue (this could be confirmed with lot numbers).The metal levels were not confirmed but if elevated would have the same root cause.-product 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: it was reported that patient's left hip was revised due to abnormal ion level, altr, periprosthetic fracture, corrosion, metallosis and osteolysis involving a metal head was reported.The event was confirmed only for altr, corrosion, metallosis based on medical review.The exact cause of the event could not be determined because insufficient information was provided.Additional information including return of the device 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 TMZF HIP STEM #3
• 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: 10400522
• MDR Text Key: 202689224
• Report Number: 0002249697-2020-01654
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510556
• UDI-Public: 04546540510556
• 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: 10/14/2021

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: 07/31/2018
• Device Model Number: 6020-0335
• Device Catalogue Number: 6020-0335
• Device Lot Number: 44345802
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 09/17/2021
• Supplement Dates FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR