MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 28MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-10-28D
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "osteolysis-like phenomena due to liner wear occurred, and revision surgery was performed, including liner replacement.".
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.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.
Additional Manufacturer Narrative
Reported event: an event regarding wear/osteolysis involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device indicated that the device has minor surface damage in the form of scratches and discoloration.Damage is consistent with explantation and time spent implanted.The yellow discoloration observed on the liner is consistent with the absorption of synovial fluid by the device.Clinician review: a review of the provided medical information by a clinical consultant indicated: "the event descriptions from the product inquiry summary states: osteolysis-like phenomena due to liner wear occurred, and revision surgery was performed, including liner replacement x-rays show a pressfit a tha in anatomic position.There is loss of medial bone on the lateral x-ray and some demineralization of bone superiorly on the ap views.No comparison x-rays were available for review.The femoral head is located centrally within the acetabulum.Wear related osteolysis cannot be confirmed from this limited documentation.The root cause of this failure cannot be determined from the documentation provided.Should additional information become available i would be happy to further this assessment.".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 liner wear.A review of the provided medical information by a clinical consultant indicated: "the event descriptions from the product inquiry summary states: osteolysis-like phenomena due to liner wear occurred, and revision surgery was performed, including liner replacement x-rays show a pressfit a tha in anatomic position.There is loss of medial bone on the lateral x-ray and some demineralization of bone superiorly on the ap views.No comparison x-rays were available for review.The femoral head is located centrally within the acetabulum.Wear related osteolysis cannot be confirmed from this limited documentation.The root cause of this failure cannot be determined from the documentation provided.Should additional information become available i would be happy to further this assessment." visual inspection of the returned device indicated that the device has minor surface damage in the form of scratches and discoloration.Damage is consistent with explantation and time spent implanted.The yellow discoloration observed on the liner is consistent with the absorption of synovial fluid by the device.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative, 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
The following was reported: "osteolysis-like phenomena due to liner wear occurred, and revision surgery was performed, including liner replacement.".

• Brand Name: TRIDENT 10° X3 INSERT 28MM 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 NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17857126
• Report Number: 0002249697-2023-01107
• Device Sequence Number: 11610517
• Product Code: LPH
• UDI-Device Identifier: 07613327039764
• UDI-Public: 07613327039764
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: 05/31/2016
• Device Catalogue Number: 623-10-28D
• Device Lot Number: 36913201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2011
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian