MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT X3 ECCENTRIC 10° 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 663-10-32D

Device Problem Material Deformation (2976)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 11/18/2008

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

Review of the medical review indicated, "on (b)(6) 2008 an exploration of the right total hip, incision and drainage, and vac dressing application was performed for a post-operative diagnosis of extensive metallosis right hip.The operative report describes a lateral approach and findings including metallosis of the right hip and thigh with damage and wear to the poly liner and head.Extensive metallosis around the proximal femoral component and behind the acetabular component was noted and the surgeon did not close the fascia and kept a sponge in the proximal femur and acetabulum after explanting the total hip components.On (b)(6) 2008 debridement was performed and a vac system was applied.Culture was noted to be (b)(6) for (b)(6).When seen on (b)(6) 2009 she was noted to be 6-centimeters short on the right lower extremity.".

Manufacturer Narrative

An event regarding wear and damage involving a trident 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 revealed: ¿on (b)(6) 2008 a revision of the right total hip was performed with removal of loose, fractured ceramic pieces.Extensive metallosis was noted and a revision total hip was performed for a diagnosis of fractured ceramic head and liner, displaced metal liner, erosion superior acetabular shell, and extensive wear debris.¿ "on (b)(6) 2008 50cc's of dark, bloody fluid was expressed from the distal thigh incision.On (b)(6) 2008 recurrent fluid accumulation was noted and drainage surgery was scheduled.On (b)(6) 2008 an exploration of the right total hip, incision and drainage, and vac dressing application was performed for a post-operative diagnosis of extensive metallosis right hip.The operative report describes a lateral approach and findings including metallosis of the right hip and thigh with damage and wear to the poly liner and head.Extensive metallosis around the proximal femoral component and behind the acetabular component was noted and the surgeon did not close the fascia and kept a sponge in the proximal femur and acetabulum after explanting the total hip components." ¿no readable post-operative x-ray of the primary right total hip arthroplasty prior to the (b)(6) 2008 post head fracture films to allow for evaluation of the initial acetabular position and seating of the alumina insert are available for review.In a ceramic/ceramic bearing a vertical acetabular position can contribute to mechanical failure.Delay in revision surgery from the time of the diagnosis of the ceramic bearing failure on (b)(6) 2008 until surgery on (b)(6) 2008 with the patient remaining active was largely responsible for the excessive fragmentation, metallosis, and diffuse distribution of the particular debris.There is nothing unique in the stryker products compared to competitive ceramic/ceramic bearings that contributed to the complications in this case which were increased by delay in revision surgery.Based upon the information available for review, no determination can be made regarding the cause of the initial fracture of the ceramic bearing four years after implantation 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 was reported for the lot indicated.Conclusions: the investigation confirmed that the event as the medical review indicated, ¿on (b)(6) 2008 an exploration of the right total hip, incision and drainage, and vac dressing application was performed for a post-operative diagnosis of extensive metallosis right hip.The operative report describes a lateral approach and findings including metallosis of the right hip and thigh with damage and wear to the poly liner and head." ¿delay in revision surgery from the time of the diagnosis of the ceramic bearing failure on (b)(6) 2008 until surgery on (b)(6) 2008 with the patient remaining active was largely responsible for the excessive fragmentation, metallosis, and diffuse distribution of the particular debris.¿ 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.

Event Description

Review of the medical review indicated, "on (b)(6) 2008 an exploration of the right total hip, incision and drainage, and vac dressing application was performed for a post-operative diagnosis of extensive metallosis right hip.The operative report describes a lateral approach and findings including metallosis of the right hip and thigh with damage and wear to the poly liner and head.Extensive metallosis around the proximal femoral component and behind the acetabular component was noted and the surgeon did not close the fascia and kept a sponge in the proximal femur and acetabulum after explanting the total hip components.On (b)(6) 2008 debridement was performed and a vac system was applied.Culture was noted to be positive for methicillin sensitive staph aureus.When seen on (b)(6) 2009 she was noted to be 6-centimeters short on the right lower extremity.".

• Brand Name: TRIDENT X3 ECCENTRIC 10° 32MM ID
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7897677
• MDR Text Key: 121011939
• Report Number: 0002249697-2018-02992
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327024838
• UDI-Public: 07613327024838
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Catalogue Number: 663-10-32D
• Device Lot Number: 11TAR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 11/30/2018
• Supplement Dates FDA Received: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 76