MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number 623-00-36F

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

Patient Problems Injury (2348); Ambulation Difficulties (2544)

Event Date 06/06/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Revision of an accolade tmz size 3.5.Removal of stem, head and poly liner as the stem dislocated (disassociated) from head and damaged poly.Trident cup remained insitu.Replaced with mdm liner.Stem replaced with depuy.

Event Description

Revision of an accolade tmz size 3.5.Removal of stem, head and poly liner as the stem dislocated (disassociated) from head and damaged poly.Trident cup remained insitu.Replaced with mdm liner.Stem replaced with competitor device.

Manufacturer Narrative

An event regarding damage involving a trident liner was reported.The event was confirmed through material analysis of the returned device.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 07 august 2020, this inspection indicated: impression markings consistent with contact against a shell was observed on the proximal surface of the insert.Yellow discoloration consistent with synovial fluid absorption was observed.Damage consistent with impingement against the stem trunnion was observed on the distal rim of the insert.Debris was observed on the articulating surface of the insert, the debris was collected for further eds analysis.Damage consistent with burnishing, scratching, and third body indentations was observed; these are common damage modes of uhmwpe.A material analysis has been performed.The report concluded:damage on the returned stem trunnion and head taper is consistent with the loss of taper lock.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Impression markings consistent with contact against a shell and yellow discoloration consistent with synovial fluid absorption was observed on the insert.Damage consistent with burnishing, scratching, and third body indentations were observed on the articulating surface of the insert.The eds analysis showed that the head (astm f1537) and stem (astm f1813) components were consistent with their respective drawings.The debris collected with head was consistent with material transfer from the stem, an oxide, and biological material.The debris collected from the liner was consistent with material transfer from the stem.A review of the provided medical records by a clinical consultant stated the following comment: no patient information is given and only an explantation date of 6/6/20 is listed.The event description states: "revision of acccolade tmz.Stem dislocated (disassociated) from head and damaged poly.Stem replaced with competitor device." undated x-ray ap right hip: uncemented tha with stem trunnion dislocated and disassociated from modular head which remains in acetabular component.Unlabeled color photo of blood stained intact modular metal head and poly insert.Unlabeled color photo of explanted stem with superior erosion of trunnion unlabeled color photo of poly insert articular surface with eccentric wear.No clinical or pmh, no patient demographics, no operative reports, no examination of explanted components.While the undated, unlabeled x-ray and specimen photos appear to confirm the event description, insufficient data is presented to create a medical report for this case.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 event of damage was confirmed through material analysis of the returned device.Damage on the returned stem trunnion and head taper is consistent with the loss of taper lock.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Impression markings consistent with contact against a shell and yellow discoloration consistent with synovial fluid absorption was observed on the insert.Damage consistent with burnishing, scratching, and third body indentations were observed on the articulating surface of the insert.The eds analysis showed that the head (astm f1537) and stem (astm f1813) components were consistent with their respective drawings.The debris collected with head was consistent with material transfer from the stem, an oxide, and biological material.The debris collected from the liner was consistent with material transfer from the stem.A review of the provided medical records by a clinical consultant stated the following comment: while the undated, unlabeled x-ray and specimen photos appear to confirm the event description, insufficient data is presented to create a medical report for this case.Further information such as clinical, patient medical history, patient demographics and operative reports are required to complete the investigation for determining a root cause.The cocr head has been identified to be within scope of an nc and a capa.No further investigation for this event is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT 0 X3 INSERT 36MM ID
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10194035
• MDR Text Key: 196395807
• Report Number: 0002249697-2020-01289
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K033716
• 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: 11/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Catalogue Number: 623-00-36F
• Device Lot Number: 30537901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention