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

Catalog Number	623-10-28E
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	09/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The liner was replaced due to osteolysis caused by liner wear.
Additional Manufacturer Narrative
Device noted as returned.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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.
Additional Manufacturer Narrative
An event regarding wear involving a trident liner was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: 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.No obvious wear is observed.-clinician review: a review of the provided medical records by a clinical consultant indicated: "as stated above this product inquiry concerns a patient who had a stryker acetabular cup and liner, used with a competitor stem and femoral head.According to the summary, the patient developed osteolysis and the revision was carried out.I can confirm that the patient had a primary total hip arthroplasty with mixed components.I cannot confirm that the patient had a revision since i have no documentation such as operational report, office notes or post revision x-rays.The root cause of this event cannot be determined with certainty.Causes of revision for osteolysis are multifactorial including surgical technique, patient activity level and bmi, and implant factors.I do have concern that stryker product was used off label with a competitor femoral stem and head.There is no way to determine with certainty whether or not this affected the onset of osteolysis.Having said that the x-ray submitted to me shows only some medial radiolucency which could be other than osteolysis.The hip was also left with poor offset and significant shortening which also could contribute." -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 osteolysis caused by liner wear.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.No obvious wear is observed.A review of the provided medical records by a clinical consultant indicated: "as stated above this product inquiry concerns a patient who had a stryker acetabular cup and liner, used with a competitor stem and femoral head.According to the summary, the patient developed osteolysis and the revision was carried out.I can confirm that the patient had a primary total hip arthroplasty with mixed components.I cannot confirm that the patient had a revision since i have no documentation such as operational report, office notes or post revision x-rays.The root cause of this event cannot be determined with certainty.Causes of revision for osteolysis are multifactorial including surgical technique, patient activity level and bmi, and implant factors.I do have concern that stryker product was used off label with a competitor femoral stem and head.There is no way to determine with certainty whether or not this affected the onset of osteolysis.Having said that the x-ray submitted to me shows only some medial radiolucency which could be other than osteolysis.The hip was also left with poor offset and significant shortening which also could contribute." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The liner was replaced due to osteolysis caused by liner wear.

• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18117805
• Report Number: 0002249697-2023-01389
• Device Sequence Number: 7512619
• Product Code: LPH
• UDI-Device Identifier: 07613327039788
• UDI-Public: 07613327039788
• 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: 2013
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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: 09/30/2017
• Device Catalogue Number: 623-10-28E
• Device Lot Number: 41411601
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2012
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 65 KG