MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 CROSSFIRE INSERT 26 MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	621-10-26F
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The clear zone was confirmed in 2016 and revision surgery of liner was done (b)(6) 2020.The date of the primary surgery is being confirmed.The doctor requested an investigation of the amount of wear on the liner.
Event or Problem Description
The clear zone was confirmed in 2016 and revision surgery of liner was done (b)(6) 2020.The date of the primary surgery is being confirmed.The doctor requested an investigation of the amount of wear on the liner.
Additional Manufacturer Narrative
Updated the manufacturing date.Reported event: an event regarding wear involving a trident liner was reported.The event was confirmed via material analysis.Method & results: product evaluation and results: visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: yellow discoloration was observed on the liner consistent with synovial fluid absorption.Damage on the liner consistent with the explantation process was observed on the proximal and articulating surfaces.Damage consistent with burnishing and scratching was observed; these are common damage modes of uhmwpe.Dimensional inspection: dimensional inspection was not performed because the event does not relate to device dimensions.Functional inspection: functional inspection was not performed because the event does not relate to device function.Ma: the returned liner was examined the aid of a stereo microscope at magnifications up to 50x.Yellow discoloration was observed on the liner consistent with synovial fluid absorption.Damage on the liner consistent with the explantation process was observed on the proximal and articulating surfaces.Damage consistent with burnishing and scratching was observed; these are common damage modes of uhmwpe.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the returned liner was examined the aid of a stereo microscope at magnifications up to 50x.Yellow discoloration was observed on the liner consistent with synovial fluid absorption.Damage on the liner consistent with the explantation process was observed on the proximal and articulating surfaces.Damage consistent with burnishing and scratching was observed; these are common damage modes of uhmwpe.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.

• Brand Name: TRIDENT 10 CROSSFIRE INSERT 26 MM 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: 10122662
• Report Number: 0002249697-2020-01030
• Device Sequence Number: 19545824
• Product Code: LPH
• UDI-Device Identifier: 07613327037692
• UDI-Public: 07613327037692
• Combination Product (Y/N): N
• PMA/510(K) Number: K983502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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: 07/31/2009
• Device Model Number: 621-10-26F
• Device Catalogue Number: 621-10-26F
• Device Lot Number: 09893801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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: 79 YR