MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° CROSSFIRE INSERT 28 MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	621-10-28E
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/21/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: device; unknown head; cat# unknown; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.H3 other text : device not returned.
Event or Problem Description
This pi is for the 1st revision.Per medical records received for pi: "she had a tha done in 2004.This subsequently had issues with instability and was revised with a head and liner exchange in 2010.".
Event or Problem Description
This pi is for the 1st revision.Per medical records received for pi: "she had a tha done in 2004.This subsequently had issues with instability and was revised with a head and liner exchange in 2010.".
Additional Manufacturer Narrative
Reported event: an event regarding instability involving an unknown liner was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "the patient had a tha in 2004 and a revision of the head and liner for instability in 2010.No records of these events were provided for review.No radiographs were provided for review.The patient had pain and reported increased metal levels and underwent revision of the acetabulum with bone grafting and of the femoral head to a ceramic on poly construct.No radiographs, pre or postoperative records were provided for review.Event confirmation: a revision surgery 11/20/2018 can be confirmed with revision of the acetabular components.Some corrosion products were noted at the time of surgery, but the taper was intact.Increased metal levels and a prior revision in 2004 cannot be confirmed.Root cause: the root cause of the 2018 revision was reported as increased metal levels and pain from corrosion at the trunnion.But these findings cannot be confirmed without additional medical record, thus a root cause cannot be ascertained." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to instability.A review of the provided medical records by a clinical consultant indicated: "the patient had a tha in 2004 and a revision of the head and liner for instability in 2010.No records of these events were provided for review.No radiographs were provided for review.The patient had pain and reported increased metal levels and underwent revision of the acetabulum with bone grafting and of the femoral head to a ceramic on poly construct.No radiographs, pre or postoperative records were provided for review.Event confirmation: a revision surgery 11/20/2018 can be confirmed with revision of the acetabular components.Some corrosion products were noted at the time of surgery, but the taper was intact.Increased metal levels and a prior revision in 2004 cannot be confirmed.Root cause: the root cause of the 2018 revision was reported as increased metal levels and pain from corrosion at the trunnion.But these findings cannot be confirmed without additional medical record, thus a root cause cannot be ascertained." the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.
Event or Problem Description
This pi is for the 1st revision.Per medical records received for pi: "she had a tha done in 2004.This subsequently had issues with instability and was revised with a head and liner exchange in 2010.".
Additional Manufacturer Narrative
The following device was also listed in this report: device; 28mm std lfit v40 head; cat# 6260-9-128; lot# 6530001.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding instability involving an trident liner was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "the patient had a tha in 2004 and a revision of the head and liner for instability in 2010.No records of these events were provided for review.No radiographs were provided for review.The patient had pain and reported increased metal levels and underwent revision of the acetabulum with bone grafting and of the femoral head to a ceramic on poly construct.No radiographs, pre or postoperative records were provided for review.Event confirmation: a revision surgery (b)(6) 2018 can be confirmed with revision of the acetabular components.Some corrosion products were noted at the time of surgery, but the taper was intact.Increased metal levels and a prior revision in 2004 cannot be confirmed.Root cause: the root cause of the 2018 revision was reported as increased metal levels and pain from corrosion at the trunnion.But these findings cannot be confirmed without additional medical record, thus a root cause cannot be ascertained." -product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to instability.A review of the provided medical records by a clinical consultant indicated: "the patient had a tha in 2004 and a revision of the head and liner for instability in 2010.No records of these events were provided for review.No radiographs were provided for review.The patient had pain and reported increased metal levels and underwent revision of the acetabulum with bone grafting and of the femoral head to a ceramic on poly construct.No radiographs, pre or postoperative records were provided for review.Event confirmation: a revision surgery (b)(6) 2018 can be confirmed with revision of the acetabular components.Some corrosion products were noted at the time of surgery, but the taper was intact.Increased metal levels and a prior revision in 2004 cannot be confirmed.Root cause: the root cause of the 2018 revision was reported as increased metal levels and pain from corrosion at the trunnion.But these findings cannot be confirmed without additional medical record, thus a root cause cannot be ascertained." the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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: TRIDENT 10° 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 18115766
• Report Number: 0002249697-2023-01385
• Device Sequence Number: 12516518
• Product Code: LPH
• UDI-Device Identifier: 07613327037739
• UDI-Public: 07613327037739
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K983502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2024

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: 10/31/2008
• Device Catalogue Number: 621-10-28E
• Device Lot Number: 1XSLW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 02/06/2024; 07/11/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 03/03/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2003
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female