MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-0435
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.H3 other text: not returned to the manufacturer.
Event or Problem Description
On (b)(6) 2008, implantation of a stryker hip prosthesis with trident screw acetabular cup, pe inlay, accolade stem, metal head.In the course now increasing instability with multiple falls.On (b)(6) 2023, evidence of premature material wear.V.A implant fracture, revision surgery on (b)(6) 2023 with massive metallosis and evidence of complete wear of the metal femoral neck.
Event or Problem Description
On (b)(6) 2008 implantation of a stryker hip prosthesis with trident screw acetabular cup, pe inlay, accolade stem, metal head.In the course now increasing instability with multiple falls.On 5/17/2023 evidence of premature material wear.V.A implant fracture, revision surgery on (b)(6) 2023 with massive metallosis and evidence of complete wear of the metal femoral neck.
Additional Manufacturer Narrative
An event regarding wear and disassociation involving an accolade stem that was mated with a lfit v40 cocr head was reported.The event was confirmed.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted head, stem, shell and liner with body fluids on it.The head seemed to be removed still seated onto the trunnion of the stem.However, once removed from the stem in a second photo, there is evidence of wear of the trunnion, black tissue and the taper of the head appears dark in colour.Clinician review: a review of the provided medical records by a clinical consultant indicated: 'this case concerns a patient who underwent a primary cementless total hip arthroplasty in 2008 and then approximately 18 years later developed head neck disassociation with metallosis requiring revision surgery.I can confirm that the patient underwent a primary total hip replacement and sustained a head neck disassociation since i was able to review x-rays showing the implants.I cannot confirm the revision surgery since i have no documentation such as office notes, operation note or post revision x-rays.The root causes of had neck disassociation with metallosis are multifactorial including surgical technique factors, trunnion and head preparation prior to implantation, patient factors such as activity level and bmi, and implant factors.The explanted femoral prosthesis and femoral head should be submitted to stryker engineers for examination and evaluation.' device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: no other similar events were reported for the lot.Conclusion: the reported accolade stem was mated with a 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 possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #4
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17307041
• Report Number: 0002249697-2023-00768
• Device Sequence Number: 15269281
• Product Code: LPH
• UDI-Device Identifier: 04546540510693
• UDI-Public: 04546540510693
• 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: 2008
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 6021-0435
• Device Lot Number: 26065502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2008
• 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: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 65 KG