MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 4.0MM BROACH; HIP INSTRUMENT

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/11/2008

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

This pi is for the intraoperative events (intraoperative fractures) on (b)(6) 2008.In review of a primary operative report for a patient for pi (b)(4), the operative report indicates: ".Sequential broaching was then performed.A 3.5mm broach demonstrating pitch change, therefore, an accolade tmzf 3.5 hip stem was impacted in the proximal femur.This immediately dropped below the level of the calcar in appearance of subsidence.The decision was made to remove this, followed by the use of the 4.0mm broach, which once again demonstrated pitch change.A 4.0 hip stem was impacted, once again without pitch change, once again suggesting signs of subsidence.It should be noted that the 4.0 stem was removed and this was broached again to assume the depth of the broach.There was noted to be a posterior cortical split on the calcar.Therefore, two separate 2.0mm dall-miles cables were placed around the proximal calcar region just above the lesser trochanter with a nice tightening in the calcar region.The 4.0mm stem was replaced.The decision was made to perform another x-ray with the implant removed.Once again, on an ap of the proximal femur a vertical split in the proximal femoral shaft was noted.The incision was extended distally so that an additional 2.0mm dall-miles cable could be placed on the proximal femoral shaft in a cerclage fashion.Once again, the 4.0mm stem seemed to show a little bit of subsidence, therefore, the decision was made to increase to a 4.5 stem.At this time, it was noticed that the most proximal cerclage wire had cut through the upper aspect of the greater trochanter completely severing this bone fragment.Therefore, this cable was removed.".

Manufacturer Narrative

An event regarding an intraoperative fracture involving an unknown rasp was reported.The event was confirmed through a clinicians review of the provided medical records.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: narrative patient underwent a metal on metal resurfacing hip replacement on august 11 2008.This procedure was complicated by a fracture in the calcar requiring cabling.{.} conclusion of assessment {.} during the first surgery an iatrogenic fracture of the calcar occurred requiring cabling.{.} -device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including lot details and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

This pi is for the intraoperative events (intraoperative fractures) on august 11, 2008.In review of a primary operative report for a patient for pi 1942620, the operative report indicates: ".Sequential broaching was then performed.A 3.5mm broach demonstrating pitch change, therefore, an accolade tmzf 3.5 hip stem was impacted in the proximal femur.This immediately dropped below the level of the calcar in appearance of subsidence.The decision was made to remove this, followed by the use of the 4.0mm broach, which once again demonstrated pitch change.A 4.0 hip stem was impacted, once again without pitch change, once again suggesting signs of subsidence.It should be noted that the 4.0 stem was removed and this was broached again to assume the depth of the broach.There was noted to be a posterior cortical split on the calcar.Therefore, two separate 2.0mm dall-miles cables were placed around the proximal calcar region just above the lesser trochanter with a nice tightening in the calcar region.The 4.0mm stem was replaced.The decision was made to perform another x-ray with the implant removed.Once again, on an ap of the proximal femur a vertical split in the proximal femoral shaft was noted.The incision was extended distally so that an additional 2.0mm dall-miles cable could be placed on the proximal femoral shaft in a cerclage fashion.Once again, the 4.0mm stem seemed to show a little bit of subsidence, therefore, the decision was made to increase to a 4.5 stem.At this time, it was noticed that the most proximal cerclage wire had cut through the upper aspect of the greater trochanter completely severing this bone fragment.Therefore, this cable was removed.".

• Brand Name: UNKNOWN 4.0MM BROACH
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8229129
• MDR Text Key: 132559456
• Report Number: 0002249697-2019-00109
• Device Sequence Number: 1
• Product Code: HTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 54