MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 16MM; SCREW, FIXATION, BONE

Catalog Number	2030-6516-1
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Headache (1880); Pain (1994); Cognitive Changes (2551); Metal Related Pathology (4530)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As per medwatch reports mw5188325, mw5188326, mw5188327, mw5188328, mw5188329, mw5188330, mw5188331, mw5188332: reporter states she had a complete hip revision on (b)(6) 2026 due to her previous hip implant leaking cobalt into her bloodstream.Reporter is still recovering from the revision 5 weeks ago and she has experienced difficulty walking.Reporter had the initial implant on (b)(6) 2012 with dr.(b)(6) hospital.Pt started experiencing extreme fatigue, headaches, cognitive issues, body aches, shortness of breath after mild activity and joint pain for the last couple of years.Within the timeframe reporter also experienced chronic fatigue syndrome.She had multiple testing done such as x-ray and mri that weren't conclusive until she had a specific mri that showed metals in bloodstream and lab work that showed heavy metal damage.She also had her gallbladder removed and suspects it may be due to heavy metals in body.Reporter states that she has seen recalls on these type of devices.
Additional Manufacturer Narrative
An event regarding abnormal ion level involving a other hip screw was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate that 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 lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 16MM
• Common Device Name: 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 25682839
• Report Number: 0002249697-2026-00563
• Device Sequence Number: 4670611
• Product Code: HWC
• UDI-Device Identifier: 07613327036978
• UDI-Public: 07613327036978
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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: 09/30/2017
• Device Catalogue Number: 2030-6516-1
• Device Lot Number: MLNLY9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female