MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT ALUMINA INSERT; HI IMPLANT

Catalog Number UNK_SHC

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 06/13/2008

Event Type  Injury  

Manufacturer Narrative

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.The following devices were also listed in this report: trident hemispherical cluster 56m, cat#502-01-56f, lot#unknown.6.5 cancellous bone screw 35mm, cat#2030-6535-1, lot#unknown.6.5 cancellous bone screw 30mm, cat#2030-6530-1, lot#unknown.Alumina v40-femoral head 32mm, +0mm nk, cat#6565-0-132, lot#unknown.Unknown size 6 tmzf stem, cat#unknown, lot#unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

As per review of medical records: "on (b)(6) 2008 the patient underwent a right trochanteric bursectomy for which the operative note describes general anesthesia and a diagnosis of chronic trochanteric bursitis.A relaxing incision of the iliotibial band and a debridement of retained ethibond sutures was described during uncomplicated surgery." this pi is for trochanteric bursectomy.

Manufacturer Narrative

An event regarding patient factors involving an unknown trident liner was reported.The event was confirmed by clinicians review.Method & results: product evaluation and results: a visual, functional and dimensional inspection was not performed as the device was not returned for analysis as it remains implanted.Clinician review: "on (b)(6) 2007 he underwent a right total hip arthroplasty.On (b)(6) 2008 the patient underwent a right trochanteric bursectomy for which the operative note describes general anesthesia and a diagnosis of chronic trochanteric bursitis.A relaxing incision of the iliotibial band and a debridement of retained ethibond sutures was described during uncomplicated surgery.On (b)(6) 2008 an injection of the right lesser trochanter and anterior acetabulum with steroids and local anesthesia was performed, which afforded pain relief.Product history review: a review of the product history records could not be performed as the device lot number is unknown.Complaint history review: a complaint history review could not be performed as the lot number is unknown.Conclusions: the event was confirmed as per clinicians review.A reviewed of provided medical records by consultant clinician revealed that, "on (b)(6) 2007 he underwent a right total hip arthroplasty.On (b)(6) 2008 the patient underwent a right trochanteric bursectomy for which the operative note describes general anesthesia and a diagnosis of chronic trochanteric bursitis.A relaxing incision of the iliotibial band and a debridement of retained ethibond sutures was described during uncomplicated surgery.On (b)(6) 2008 an injection of the right lesser trochanter and anterior acetabulum with steroids and local anesthesia was performed, which afforded pain relief.In this complicated case of a multiple operated upon right hip there is no evidence of prosthetic design, manufacturing, or material factors causing the persistent symptoms.The trochanteric bursitis was unrelated and the iliopsoas tendinitis may have been caused by anterior overlap of the acetabular shell, which at revision was described as being repositioned in more anteversion and less abduction.The metallic transfer marks, as well as the description of "neck impingement.On the cup", could also relate to acetabular position and resultant subluxation.There was no radiographic evidence of failure of fixation and the question of persistent infection was never completely resolved in the documents reviewed and could account for the continued symptomology.Examination of the explanted components would be helpful to further analyze this case." no further investigation for this event is possible.If devices and / or additional information become available, this record will be reopened.

Event Description

As per review of medical records: "on (b)(6) 2008 the patient underwent a right trochanteric bursectomy for which the operative note describes general anesthesia and a diagnosis of chronic trochanteric bursitis.A relaxing incision of the iliotibial band and a debridement of retained ethibond sutures was described during uncomplicated surgery." this pi is for trochanteric bursectomy.

• Brand Name: UNKNOWN TRIDENT ALUMINA INSERT
• Type of Device: HI IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7960092
• MDR Text Key: 123511093
• Report Number: 0002249697-2018-03305
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 95