MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 30MM; SCREW, FIXATION, BONE

Model Number 2030-6530-1

Device Problem Corroded (1131)

Patient Problems Foreign Body Reaction (1868); Joint Laxity (4526); Metal Related Pathology (4530)

Event Date 02/19/2020

Event Type  Injury  

Event Description

Left hip revision for pain, pseudo tumor, and elevated cobalt levels.Cup, screws, insert, and head were revised.Competitor cup, screws, and insert were used along with a stryker universal taper ceramic head.Update based on medical review.The preoperative diagnoses and postoperative diagnoses were the same: "pseudo-tumor left hip following left total hip arthroplasty.Cobalt and chromium toxicity following left total hip arthroplasty.Painful left hip.Instability/subluxation events following left total hip arthroplasty.Corrosion identified on the shell at the screw holes per the provided op report: "through the holes one could see extensive evidence for corrosion material through 3 of the 4 screw holes.This material was black and seemed consistent with corrosion".

Manufacturer Narrative

Reported event:  an event regarding  altr, corrosion and abnormal ion level involving an other hip screw was reported. the event was not confirmed.    method & results:  -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.  -clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement about 4 years after implantation for pseudotumor and elevated ion levels.I can confirm that this event took place since i was able since i was able to review the revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of pseudotumor and elevated ion levels are multifactorial including surgical technique factors, patient factors including activity level and bmi, and implant factors.-device history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been 1 other similar events for the lot referenced related to the same device/patient.Conclusion:  the reported patient had left hip revision for pain, pseudo tumor, instability/subluxation and elevated cobalt levels.A review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement about 4 years after implantation for pseudotumor and elevated ion levels.I can confirm that this event took place since i was able since i was able to review the revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of pseudotumor and elevated ion levels are multifactorial including surgical technique factors, patient factors including activity level and bmi, and implant factors.The issue of instability/subluxation was not confirmed.Further information such as pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 30MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14655839
• MDR Text Key: 294021231
• Report Number: 0002249697-2022-00815
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327037005
• UDI-Public: 07613327037005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2020
• Device Model Number: 2030-6530-1
• Device Catalogue Number: 2030-6530-1
• Device Lot Number: HY3JYX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 78 KG