MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL SOLID BK 62MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	500-01-62G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteolysis (2377); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lift anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2007 and was revised on (b)(6) 2020.It is further alleged that he suffered injuries as a result of implantation and explantation of the devices at issue, device recall and excessive levels of chromium and cobalt in his blood.Update on 03-mar-2022 per clinician review: "[.] an operative note by dr.Dated (b)(6) 2020 is provided.The preoperative diagnosis was ¿mechanical loosening of prosthetic hip¿ and the postop diagnosis was the same.The operation performed was a revision right total hip arthroplasty.The surgeon used a cementless 70 mm shell, a polyethylene with a 28 mm inner diameter, a wagner sl femoral stem was utilized, demineralized bone putty, and a 28 mm femoral head was utilized.Femoral component was grossly loose.There was no evidence of infection.The surgeon describes a huge amount of osteolysis with "amorphous sludge type of whitish gray material".He states that the femoral head was disassociated from the femoral stem and there was a large amount of corrosive black typical material on both the male trunnion as well as the female portion of the femoral head.[.] " per operative report: "[.] the explant osteotome was used to remove the well-fixed acetabular component.There were no significant defects behind the acetabular shell.[.] ".
Additional Manufacturer Narrative
Reported event: an event regarding revision for unspecified reason involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: this inquiry reports the failure of a right total hip arthroplasty approximately 13 years after implantation due to femoral loosening, osteolysis, and head disassociation.I can confirm this event took place since i was able to read the revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of femoral loosening or multifactorial including surgical technique factors, patient activity factors and patient¿s height and weight.Causes of osteolysis are multifactorial including poly wear and other types of particle synovitis.Causes of head disassociation are multifactorial including trunnion failure, and corrosion.In this case i cannot confirm corrosion since there is no metallurgical analysis.Product history review: review of the device history records indicate the 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 well-fixed acetabular component was also revised.There were no significant defects behind the acetabular shell.The exact cause of the event could not be determined.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.

• Brand Name: TRIDENT HEMISPHERICAL SOLID BK 62MM
• 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: 13937767
• Report Number: 0002249697-2022-00446
• Device Sequence Number: 17220739
• Product Code: LPH
• UDI-Device Identifier: 07613153072966
• UDI-Public: 07613153072966
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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: 06/30/2009
• Device Model Number: 500-01-62G
• Device Catalogue Number: 500-01-62G
• Device Lot Number: 9789101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2004
• 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: 54 YR
• Patient Sex: Male