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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE Back to Search Results
Catalog Number 625-0T-36G
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Swelling (2091); Injury (2348); Joint Dislocation (2374); Ambulation Difficulties (2544); Inadequate Osseointegration (2646)
Event Date 12/18/2017
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.
 
Event Description
It was reported by the patient as a result of a legal claim that allegedly after the implantation he developed pain and swelling which worsens as time went by.During the next two years besides the pain and swelling the leg started to thump when he walked and sometimes the hip would lock up and could not move.It is further alleged that the patient was revised on (b)(6) 2017 and during the procedure the surgeon found that the ball had disintegrated in the leg and four hours were spent picking out shards and splinters that had embedded in his leg.Update per medical review: ¿on (b)(6) 2017 he had a left hip aspiration under local anesthesia and fluoroscopic control.Toe fluid was sent for gram stain, culture and cell count.Lab report of results of (b)(6) 2017 left hip aspirate results: "no organisms seen" on gram stain and "no growth at 3 days" on culture.Cell count from aspirate is not diagnostic of infection.¿ ¿on (b)(6) 2017 a revision left total hip arthroplasty (both components) for a pre­ and post-operative diagnosis of "left hip pain status-post tha, dislocated left hip, loosening of hardware".A brief operative report describes spinal anesthesia and a lateral approach.The operative report notes, "total hip was loose and reamed.Reamed up to anatomic size.Stable in all planes.Uncomplicated surgery.Implant: stem size 6, head 28mm, acetabulum 60mm, liner - poly on ceramic." uncomplicated surgery was described and the patient was discharged home on (b)(6) 2017.An implant sheet indicates an mdm liner, x3 outer diameter 48mm, ceramic femoral head, a 28/54 restoration/adm insert, all by stryker, were utilized.¿.
 
Event Description
It was reported by the patient as a result of a legal claim that allegedly after the implantation he developed pain and swelling which worsens as time went by.During the next two years besides the pain and swelling the leg started to thump when he walked and sometimes the hip would lock up and could not move.It is further alleged that the patient was revised on (b)(6) 2017 and during the procedure the surgeon found that the ball had disintegrated in the leg and four hours were spent picking out shards and splinters that had embedded in his leg.Update per medical review: ¿on (b)(6) 2017 he had a left hip aspiration under local anesthesia and fluoroscopic control.Toe fluid was sent for gram stain, culture and cell count.Lab report of results of (b)(6) 2017 left hip aspirate results: "no organisms seen" on gram stain and "no growth at 3 days" on culture.Cell count from aspirate is not diagnostic of infection.¿ ¿on (b)(6) 2017 a revision left total hip arthroplasty (both components) for a pre­ and post-operative diagnosis of "left hip pain status-post tha, dislocated left hip, loosening of hardware".A brief operative report describes spinal anesthesia and a lateral approach.The operative report notes, "total hip was loose and reamed.Reamed up to anatomic size.Stable in all planes.Uncomplicated surgery.Implant: stem size 6, head 28mm, acetabulum 60mm, liner - poly on ceramic." uncomplicated surgery was described and the patient was discharged home on (b)(6) 2017.An implant sheet indicates an mdm liner, x3 outer diameter 48mm, ceramic femoral head, a 28/54 restoration/adm insert, all by stryker, were utilized.¿.
 
Manufacturer Narrative
An event regarding dislocation and loosening involving a trident alumina liner was reported.The event was not confirmed by medical review.Method & results: product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿on (b)(6) 2017 he had a left hip aspiration under local anesthesia and fluoroscopic control.The fluid was sent for gram stain, culture and cell count.Lab report of results of (b)(6) 2017 left hip aspirate results: "no organisms seen" on gram stain and "no growth at 3 days" on culture.Cell count from aspirate is not diagnostic of infection.¿ ¿on (b)(6) 2017 a revision left total hip arthroplasty (both components) for a pre­ and post-operative diagnosis of "left hip pain status-post tha, dislocated left hip, loosening of hardware".A brief operative report describes spinal anesthesia and a lateral approach.The operative report notes, "total hip was loose and reamed.Reamed up to anatomic size.Stable in all planes.Uncomplicated surgery.Implant: stem size 6, head 28mm, acetabulum 60mm, liner - poly on ceramic." uncomplicated surgery was described and the patient was discharged home on (b)(6), 2017.An implant sheet indicates an mdm liner, x3 outer diameter 48mm, ceramic femoral head, a 28/54 restoration/adm insert, all by stryker, were utilized.¿ ¿no examination of explanted components is available and there is no documentation or radiographic evidence confirming "dislocated left hip and loosening of hardware" noted in the diagnosis of the (b)(6) 2017 operative report or evidence of fractured alumina head.X-rays and implant sheets suggest only the bearing was changed to an mdm with retention of the stem and acetabular shell.There is no evidence as a result of review of the revision operative report, the surgical pathology report of soft tissue only without ceramic debris (not including explanted components) or pre-revision x-rays to support the patient's statement that".During the procedure the surgeon found that the ball had disintegrated in the leg and four hours were spent picking out shards and splinters that had embedded in his leg".There is no evidence of failure of fixation or of any clinical problems of the left total hip arthroplasty related to factors of implant design, manufacturing or materials.¿ product history review: review of the product 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 this lot.Conclusions: the reported event for pain, swelling, thumping sound when walking, ball disintegration, shards, splinters, loosening and dislocation was not confirmed.It was noted in the medical review ¿no examination of explanted components is available and there is no documentation or radiographic evidence confirming "dislocated left hip and loosening of hardware" noted in the diagnosis of the (b)(6) 2017 operative report or evidence of fractured alumina head.X-rays and implant sheets suggest only the bearing was changed to an mdm with retention of the stem and acetabular shell.There is no evidence as a result of review of the revision operative report, the surgical pathology report of soft tissue only without ceramic debris (not including explanted components) or pre-revision x-rays to support the patient's statement that".During the procedure the surgeon found that the ball had disintegrated in the leg and four hours were spent picking out shards and splinters that had embedded in his leg".There is no evidence of failure of fixation or of any clinical problems of the left total hip arthroplasty related to factors of implant design, manufacturing or materials.¿.
 
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Brand Name
TRIDENT ALUMINA INSERT
Type of Device
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 Key7992450
MDR Text Key124610363
Report Number0002249697-2018-03467
Device Sequence Number1
Product Code MRA
UDI-Device Identifier04546540516862
UDI-Public04546540516862
Combination Product (y/n)N
PMA/PMN Number
P000013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 11/28/2018
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 Date01/31/2019
Device Catalogue Number625-0T-36G
Device Lot Number46606704
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/25/2018
Initial Date FDA Received10/22/2018
Supplement Dates Manufacturer Received10/31/2018
Supplement Dates FDA Received11/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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