MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 CROSSFIRE INSERT 28 MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	621-00-28E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	06/23/2020
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 liner head was replaced due to dislocation.The revision was completed successfully.The reporting surgeon's request: please investigate whether there was any wear on the implant or there was a problem with the product.
Event or Problem Description
The liner head was replaced due to dislocation.The revision was completed successfully.The reporting surgeon's request: please investigate whether there was any wear on the implant or there was a problem with the product.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection of the returned device noted that the device was returned in used condition.Scratch marks visible on the surface of the device possibly implantation/explantation marks.Material analysis is not performed as dislocation is not related to material integrity issue.Functional and dimensional inspection were not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Clinician review: a review of the provided medical records by a clinical consultant stated that," no clinical or pmh, no patient demographics, no operative reports, no examination of explanted components.Based upon the single x-ray provided, no response to the event description nor preparation of a medical report is possible 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: it was reported that the patient's hip was revised due to dislocation.Visual inspection of the returned device noted that the device was returned in used condition.Scratch marks visible on the surface of the device possibly implantation/explantation marks.Material analysis is not performed as dislocation is not related to material integrity issue.Functional and dimensional inspection were not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.The available medical records were provided to the consulting clinician for a review which was deemed insufficient to confirm the event.The event could not be confirmed nor the exact cause be determined because insufficient information was provided.Additional information including operative reports, progress notes are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.

• Brand Name: TRIDENT 0 CROSSFIRE INSERT 28 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: 10269952
• Report Number: 0002249697-2020-01431
• Device Sequence Number: 11574933
• Product Code: LPH
• UDI-Device Identifier: 07613327037432
• UDI-Public: 07613327037432
• Combination Product (Y/N): N
• PMA/510(K) Number: K983502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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 Expiration Date: 07/31/2013
• Device Model Number: 621-00-28E
• Device Catalogue Number: 621-00-28E
• Device Lot Number: 27297401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 01/22/2021
• 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: 65 YR