MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number 625-0T-32F

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 01/18/2023

Event Type  Injury  

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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

As reported: "revision of left total hip.Surgeon says patient has painful osteolysis in the greater trochanter and behind the cup.Surgeon says ceramic liner may not have been fully seated." spoke to rep.A femoral head and liner were revised, shell and screw were retained.

Event Description

As reported: "revision of left total hip.Surgeon says patient has painful osteolysis in the greater trochanter and behind the cup.Surgeon says ceramic liner may not have been fully seated." spoke to rep.A femoral head and liner were revised, shell and screw were retained.

Manufacturer Narrative

An event regarding osteolysis involving a trident liner was reported.The event for osteolysis was confirmed.Method & results: device evaluation and results: not performed as the device was not returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant indicated: narrative: little medical information was provided for review.There was a tha performed with an alumina-alumina bearing.Osteolysis developed in the trochanter and somewhat in the acetabulum.By report only a revision surgery was performed with exchange of the bearing components.The liner may not have been fully seated according to the event description, but no intraoperative data was provided for review.Conclusion/assessment: osteolysis developed in the trochanter and behind the acetabulum in an alumina-alumina bearing tha over a 19 year period.Apparently the osteolysis was painful and led to revision and it was implied that the liner was not fully seated.However, no records documenting the revision, patient symptoms and or the position of the liner were provided for review.Event confirmation: osteolysis in the trochanter and acetabulum can be confirmed.A revision surgery cannot be confirmed.Patient symptoms cannot be confirmed.Root cause: a root cause for the osteolysis cannot be ascertained without additional medical information.A revision cannot be confirmed but could be explained by the osteolysis.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been no other similar events for the reported lot.Conclusions: it was reported that the patient was revised due to osteolysis.As per the medical review 'event confirmation: osteolysis in the trochanter and acetabulum can be confirmed.A revision surgery cannot be confirmed.Patient symptoms cannot be confirmed.Root cause: a root cause for the osteolysis cannot be ascertained without additional medical information.A revision cannot be confirmed but could be explained by the osteolysis.' no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16322613
• MDR Text Key: 309033565
• Report Number: 0002249697-2023-00143
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 04546540516855
• UDI-Public: 04546540516855
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2008
• Device Model Number: 625-0T-32F
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: U7644501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female