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-36G
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Noise, Audible (3273)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Injury (2348)
Date of Event	09/12/2003
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection, pain and audible noise involving a trident alumina liner was reported.The event for infection was not confirmed however, audible noise 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 and x-rays by a clinical consultant indicated: "on (b)(6) 2003 he underwent a primary right total hip arthroplasty for a diagnosis of osteoarthritis of the right hip." [.] "an office visit of (b)(6) 2003 notes the patient to be "doing well".When seen on (b)(6) 2003 he was allowed weightbearing as tolerated and was to return in two months.He was seen on (b)(6) 2003 in the emergency room where it was noted, "hip started popping.Seems like sciatic pain"."" [.] "he had a consultation on (b)(6) 2011 where it was noted, "failing ceramic right total hip arthroplasty.Acetabular component may be too flat and is causing impingement which has led to, squeaking and probable ceramic failure, getting stiffer, more pain.Plan: revision".On (b)(6) 2011 a revision of the right acetabulum was performed for a diagnosis of painful right total hip arthroplasty.The operative report describes spinal anesthesia and use of the previous posterolateral approach.At surgery an anterior hip impingement with a retroverted acetabular component was noted.The alumina head had "one small area of striping; otherwise, normal"." [.] "x-ray printouts available for review include a series dated (b)(6) 2011, which is an ap of a right uncemented total hip arthroplasty, which is reduced.A radiodense, large head is noted and the components are in nominal position." [.] "while no pre-op x-rays are available for review, the revising surgeon noted malposition of the acetabular component of the primary total hip arthroplasty resulted in impingement and subluxation of the ceramic-ceramic bearing with a single stripe wear noted on the alumina head.These factors have been described as associated with increased incidence of squeaking in ceramic-ceramic hip arthroplasties.This may be relevant in this case." 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 and sterile lot indicated.Conclusions: the reported event of infection could not be confirmed as insufficient information was provided.A trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.Audible noise was confirmed due to malposition of the shell which "resulted in impingement and subluxation of the ceramic-ceramic bearing with a single stripe wear noted on the alumina head." the consulting clinician indicated, "these factors have been described as associated with increased incidence of squeaking in ceramic-ceramic hip arthroplasties.".
Event or Problem Description
It was reported through the filing of a lawsuit, that allegedly the patient received a trident ceramic acetabular system.It is alleged that patient "has suffered and continues to suffer both injuries and damages, including but not limited to: past, present and future physical and metal pain and suffering and extraordinary loosening and infection.As a result of the implantation of the device, the patient required a revision surgery on (b)(6) 2011.Update as per medical review: clinician concluded, "while no pre-op x-rays are available for review, the revising surgeon noted malposition of the acetabular component of the primary total hip arthroplasty resulted in impingement and subluxation of the ceramic-ceramic bearing with a single stripe wear noted on the alumina head.

• 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: 7556626
• Report Number: 0002249697-2018-01648
• Device Sequence Number: 19441969
• Product Code: MRA
• UDI-Device Identifier: 04546540516862
• UDI-Public: 04546540516862
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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: 12/30/2007
• Device Catalogue Number: 625-0T-36G
• Device Lot Number: U5698405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/31/2018
• 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; Other; Required Intervention