MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 623-00-36F

Device Problem Material Deformation (2976)

Patient Problems Inflammation (1932); Injury (2348); Joint Dislocation (2374); Reaction (2414)

Event Date 01/28/2011

Event Type  Injury  

Manufacturer Narrative

An event regarding wear involving an trident liner was reported.The event was not confirmed.Method and results: product evaluation and results: not performed as no products were returned for evaluation.A review of the provided medical records and/or x-rays by a clinical consultant revealed: " on (b)(6) 2006 he underwent a primary right total hip arthroplasty for osteoarthritis of the right hip for which an operative report describes spinal anesthesia and a posterolateral approach.On (b)(6) 2007 the patient was noted to be "much better.No drainage", and on (b)(6) 2008 it was noted, '"all desired activities without problems.X-ray: good position, equal leg lengths.On (b)(6) 2009 he was admitted to the hospital and on (b)(6) 2009 a closed reduction of a dislocated right total hip arthroplasty was performed under general anesthesia.Attempts in the emergency room to reduce this were unsuccessful, and after a successful reduction he was admitted overnight.On (b)(6) 2009 he underwent a closed reduction once again for a dislocated right total hip under general anesthesia.After reduction, flexing the hip to 90° and internally rotating it more than 20° tended to result in dislocation.X-ray showed "femoral head disassociated from morse taper.Tip of taper within the acetabulum".He was to be referred for revision surgery.On (b)(6) 2011 a revision of the right total hip was performed for right hip instability with disassociation femoral head from stem.The findings were, "metal staining synovium, synovial fluid and pseudocapsule.Femoral head disassociated.Damage to poly liner with full thickness wear and minimal damage to shell.Superior scratches.Trunnion significantly worn.Not possible.Reattach new head." as a result, they removed the stem, head, and liner.The report further notes, "gram stain and cell count negative for infection.Stem was removed.Bone ingrowth relatively minimal", but the stem was removed with osteotomes.The acetabulum was noted to be stable.An office visit of (b)(6) 2011 noted the patient "doing just fine; walking without aids".On a visit of (b)(6) 2011 the note states, "doing well.X-ray: well-fixed and well aligned.".On (b)(6) 2011 it was noted he fell in the bathroom today and the x-ray revealed a posterior dislocation that was treated with closed reduction under sedation in the emergency room.X-ray printouts available for review include a series dated (b)(6) 2006, which includes an ap of the right hip, times two, and a lateral of the right hip of poor quality, demonstrating an uncemented right total hip arthroplasty with no screws in the acetabulum.The hip is reduced and in nominal position.On (b)(6) "2208" an ap of the pelvis, an ap of the right hip, times two, and a lateral of the right hip are unchanged.A (b)(6) 2009 ap of the right with the tip of the stem not visualized is unchanged.On (b)(6) 2009 an ap of the right hip demonstrates a superior dislocation and an ap spot film on the same day demonstrates the hip reduced.An (b)(6) 2011 ap and lateral of the lumbosacral spine allows visualization of two-thirds of the right acetabulum seen at the bottom of the film on the ap of the spine, and the hip appears reduced." product history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the reported event was not confirmed by medical review.Review of the provided medical records revealed that "there are no x-rays of the disassociated femoral head and no examination of the explanted components provided for review.The apparent delay of eleven days from the disassociation incident to the revision surgery, during which this large male patient was painlessly ambulating with the empty trunnion articulating with the acetabular insert explains the significant damage to the poly and the metallosis found.The possibility that the modular head was loosened from its firm seating on the trunnion during one of the closed reduction attempts and was never firmly reseated cannot be ruled out.When the patient was subsequently involved in a maneuver that would have resulted in severe force applied to the reduced hip it disassociated rather than dislocated.Examination of the explanted head and stem would be valuable in determining causation, but there is no evidence that factors of faulty prosthetic design, manufacturing, or materials were responsible for this clinical situation." no further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

On (b)(6) 2011 a revision of the right total hip was performed for right hip instability with disassociation femoral head from stem.The findings were, "metal staining synovium, synovial fluid and pseudocapsule.Femoral head disassociated.Damage to poly liner with full thickness wear and minimal damage to shell.Superior scratches on the trunnion significantly, it wasn't possible to attached a new head.

Manufacturer Narrative

This record is a duplicate of 0002249697-2018-03541.Therefore, we will be cancelling it.

Event Description

On (b)(6) 2011 a revision of the right total hip was performed for right hip instability with disassociation femoral head from stem.The findings were, " metal staining synovium, synovial fluid and pseudocapsule.Femoral head disassociated.Damage to poly liner with full thickness wear and minimal damage to shell.Superior scratches on the trunnion significantly, it wasn't possible to attached a new head.

• Brand Name: TRIDENT 0° X3 INSERT 36MM 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: 7919046
• MDR Text Key: 122049372
• Report Number: 0002249697-2018-03121
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039535
• UDI-Public: 07613327039535
• Combination Product (y/n): N
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

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: 09/30/2011
• Device Catalogue Number: 623-00-36F
• Device Lot Number: 62JMNA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 10/01/2018
• Supplement Dates FDA Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 101