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

Catalog Number	623-00-36E
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Joint Dislocation (2374)
Date of Event	09/11/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been 3 other events for the lot referenced, however, they are for the same patient.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
On (b)(6) 2015 it was noted, "twisted to answer the phone" and the right hip dislocated for which she underwent a closed reduction.She dislocated again on (b)(6) 2015, and underwent closed reductions.This report covers the closed reduction on (b)(6) 2015.
Additional Manufacturer Narrative
An event regarding dislocation involving a trident liner was reported.The event was confirmed.Method & results: product evaluation and results: visual, dimensional, functional & material analysis inspection: not performed as device not returned.Medical records received and evaluation: review of medical records by a consulting clinician indicated: "on (b)(6) 2009 she underwent a primary right total hip arthroplasty for a diagnosis of right hip osteoarthritis.On (b)(6) 2012 she was seen complaining of right lateral hip and groin pain for eight to ten months.Physical examination revealed pain in the right greater trochanter with internal and external rotation of the hip, and pain to palpation of the right sacroiliac joint.The impression was greater trochanteric bursitis, which was injected with depo-medrol and lidocaine.An x-ray of the right hip noted, "good placement and fixation acetabular and femoral components.(b)(6)2015 with eighty percent relief of pain.She had no complaints referable to her right hip.She was seen in the emergency room on (b)(6) 2015 complaining of right hip pain for two days and only with weightbearing.X-ray showed "right acetabular component displaced from native acetabulum".The plan was revision surgery.On (b)(6) 2015 she underwent revision of the right acetabulum and femoral head for a diagnosis of "loosening right acetabular component".The operative report describes general anesthesia and use of the previous surgical incision.The operative report notes, "large amount of fluid.Hemosiderin stain from acetabular loosening.Removed femoral head from c-taper some corrosion product present.Removed acetabular component and screw without difficultyon (b)(6) 2015 it was noted, "twisted to answer the phone" and the right hip dislocated for which she underwent a closed reduction.She dislocated again on (b)(6) 2015, and underwent closed reductions.Multiple undated x-rays of the right hip show an uncemented total hip arthroplasty with one screw in the acetabulum.The hip is reduced and in nominal position.Several show the acetabulum having migrated verticallyx-rays dated (b)(6) 2015 are multiple views of the right hip in which the acetabular component is now 90° vertical and rotated out of the host acetabulum.There is no examination of the explanted components.Failure of fixation after a primary acetabular component has been in situ six years may have been associated with metabolic and or medication factors, single screw augmentation, or failure to gain firm fixation in osteoporotic bone reamed to 52 millimeters for a 52 primary cup.There is no evidence that factors of faulty component design, manufacturing or materials contributed to this clinical situation." -product history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been 3 other events for the lot referenced, however, they are for the same patient.Conclusions: the event of dislocation was confirmed as noted by a consulting clinician: "on (b)(6) 2015 it was noted, "twisted to answer the phone" and the right hip dislocated for which she underwent a closed reduction.She dislocated again on (b)(6) 2015 , and underwent closed reductions." the exact root cause could not be determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
On (b)(6) 2015 it was noted, "twisted to answer the phone" and the right hip dislocated for which she underwent a closed reduction.She dislocated again on (b)(6) 2015 and (b)(6) 2015 , and underwent closed reductions.This report covers the closed reduction on (b)(6) 2015.

• Brand Name: TRIDENT 0° X3 INSERT 36MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7621513
• Report Number: 0002249697-2018-01900
• Device Sequence Number: 1383011
• Product Code: LPH
• UDI-Device Identifier: 07613327025323
• UDI-Public: 07613327025323
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

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: 06/30/2020
• Device Catalogue Number: 623-00-36E
• Device Lot Number: E67AE8
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 07/23/2018
• 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; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 61