MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 4.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-4535
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/11/2008
Type of Reportable Event	Serious Injury
Additional 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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem 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.".
Additional Manufacturer Narrative
An event regarding an intraoperative fracture involving an accolade stem 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: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative 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 or Problem 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: ACCOLADE 132 SIZE 4.5
• 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: 8229208
• Report Number: 0002249697-2019-00110
• Device Sequence Number: 19361124
• Product Code: LPH
• UDI-Device Identifier: 04546540510631
• UDI-Public: 04546540510631
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 01/31/2013
• Device Catalogue Number: 6020-4535
• Device Lot Number: 25387501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 04/19/2019
• 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: 60 YR
• Patient Weight: 54