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

Catalog Number	625-0T-28D
Medical Device Problem Codes	Degraded (1153); Mechanical Problem (1384)
Health Effect - Clinical Codes	Hematoma (1884); Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)
Date of Event	11/13/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding impingement and metallosis involving a ceramic liner was reported.The event was confirmed by medical review.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant concluded: ¿on (b)(6) 2011 her tests were negative for infection and she had no pain at that time.On (b)(6) 2012 she noted "pain for five months.Told hematoma returned".Mri showed "possible metallosis".Physical examination revealed mild pain on rotation of the left hip.X-ray showed good alignment and no wear or loosening bilaterally.The plan was bearing revision.On (b)(6) 2012 a revision of the left total hip arthroplasty to change the liner and head was performed for a diagnosis of painful left total hip arthroplasty." [.] ".At surgery an impingement of the titanium neck on the acetabular rim with metallosis in the joint and anterior cyst "likely due to metallosis" was noted.The bearing was changed to a 32/10° poly and a 32/0 cobalt-chromium head.Uncomplicated surgery was described and the patient was subsequently discharged home on (b)(6) 2012.¿ [¿] ¿no examination of the explanted ceramic-ceramic bearing and no surgical pathology report are available.Metallosis as described from impingement of the neck of the femoral component on the metallic rim of the ceramic acetabular insert was the result of version of either the femoral and/or acetabular components and not related to factors of prosthetic design, manufacturing, or materials.The clinical situation was apparently resolved by changing the bearing to metal-poly components at revision surgery on (b)(6) 2012." product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the metallosis was caused by the impingement between the metallic rim of the ceramic insert on the neck of the femoral component.The clinician indicated that the possible root cause for the version of either the femoral and/or acetabular components, however the x-ray images provided reveal that the images are in nominal position.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.Not returned.
Event or Problem Description
"on (b)(6) 2012 she noted "pain for five months.Told hematoma returned".Mri showed "possible metallosis".[.] during the left hip revision surgery, "at surgery an impingement of the titanium neck on the acetabular rim with metallosis in the joint and anterior cyst "likely due to metallosis" was noted." update 17-jan-2019: medical review clarified that tritanium neck impinged on the metal rim of the ceramic insert.

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8264408
• Report Number: 0002249697-2019-00233
• Device Sequence Number: 2100195
• Product Code: MRA
• UDI-Device Identifier: 04546540516831
• UDI-Public: 04546540516831
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2019

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: 06/30/2008
• Device Catalogue Number: 625-0T-28D
• Device Lot Number: U5965101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/21/2019
• 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
• Patient Weight: 45