MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-32E
Medical Device Problem Codes	Degraded (1153); Fracture (1260)
Health Effect - Clinical Codes	Hip Fracture (2349); Insufficient Information (4580)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Right total hip replacement broken stem.Exeter trident in situ.Update: verbal findings from the revision surgery performed by on (b)(6) 2020: exeter stem broken mid neck.Body of the exeter stem sitting in approximately 10-15 degrees of retro version.Evidence of impingement on the acetabular liner.
Additional Manufacturer Narrative
Reported event an event regarding damage involving a trident liner was reported.The event was confirmed based on inspection.Method & results: product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar).Damage consistent with the explantation process was observed on the proximal rim of the liner.Damage consistent with impingement was observed on the distal rim of the insert.Damage on the articulating surface is consistent with burnishing and scratching; these are common damage modes of uhmwpe.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the dimensional aspects are not in question.Material analysis: a material analysis has been performed.The report concluded:the returned stem had fractured in fatigue from the superior to inferior surfaces, with final fracture occurring in overload.Damage consistent with impingement against the stem was observed on the distal rim of the liner.Plastic surface deformation consistent with micro-motion at the stem-cement interface was observed.Eds showed that the stem chemistry was consistent with an astm f1586 alloy which is consistent with the drawing.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: confirmation:the event was confirmed.There was material failure and fracture of the exeter stem at the trunnion base.Root cause: there were 3 key issues: there was a fractured stem.There appeared to be stem-polyethylene impingement.The stem was found retroverted.How these interplayed for the end point are unclear.Additional materials would be helpful to assess root cause and chronology of key issues above including postoperative clinical data, x-rays from the post-operative period of the primary hip and a materials evaluation of the stem and explants.Product history review: could not be performed as lot code information was not provided.  complaint history review: could not be performed as lot code information was not provided.  conclusions: it was reported that there was evidence of impingement on the acetabular liner.The event was confirmed based on inspection.A material analysis has been performed.The report concluded:the returned stem had fractured in fatigue from the superior to inferior surfaces, with final fracture occurring in overload.Damage consistent with impingement against the stem was observed on the distal rim of the liner.Plastic surface deformation consistent with micro-motion at the stem-cement interface was observed.Eds showed that the stem chemistry was consistent with an astm f1586 alloy which is consistent with the drawing.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.A review of the provided medical records by a clinical consultant stated the following comment: confirmation:the event was confirmed.There was material failure and fracture of the exeter stem at the trunnion base.Root cause: there were 3 key issues: there was a fractured stem.There appeared to be stem-polyethylene impingement.The stem was found retroverted.How these interplayed for the end point are unclear.Additional materials would be helpful to assess root cause and chronology of key issues above including postoperative clinical data, x-rays from the post-operative period of the primary hip and a materials evaluation of the stem and explants.
Event or Problem Description
Right total hip replacement broken stem.Exeter trident in situ.Update: verbal findings from the revision surgery performed by on (b)(6)2020: exeter stem broken mid neck.Body of the exeter stem sitting in approximately 10-15 degrees of retro version.Evidence of impingement on the acetabular liner.

• Brand Name: TRIDENT 10 X3 INSERT 32MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10838560
• Report Number: 0002249697-2020-02452
• Device Sequence Number: 16869780
• Product Code: LPH
• UDI-Device Identifier: 07613327039856
• UDI-Public: 07613327039856
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: 623-10-32E
• Device Catalogue Number: 623-10-32E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR