HydroSet XTRecalls & reported problems across all models

We found 4 models of HydroSet XT by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Jul 25, 2019 and Feb 28, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HydroSet XT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 15, 2018Terminated

   Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19

   Z-0678-2019 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

2. Nov 15, 2018Terminated

   Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19

   Z-0677-2019 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

Most reported HydroSet XT problems

HydroSet XT models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HydroSet XT 897003

  FILLER, BONE VOID, CALCIUM COMPOUND
  1 recall1 report
• HydroSet XT 897005

  FILLER, BONE VOID, CALCIUM COMPOUND
  1 recall1 report
• HydroSet XT 897010

  FILLER, BONE VOID, CALCIUM COMPOUND
  1 report
• HydroSet XT 897015

  FILLER, BONE VOID, CALCIUM COMPOUND
  1 report

Recent HydroSet XT adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT WAS IMPLANTED WITH A VARIAX PLATE, VARIAX SCREWS, A 2.5 CC VITOSS BA2X FOAM PACK, AND 15 CC HYDROSET XT IN THEIR FOOT FOLLOWING REMOVAL OF A BONE MASS. BEGINNING APPROXIMATELY FOUR-MONTHS POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING "SEVERE FOOT PAIN" AND DIFFICULTY WALKING. THIS REPORT CAPTURES THE 15 CC HYDROSET XT.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 18804141 ↗
• MalfunctionJul 25, 2019Use of Device Problem; Crack; Fracture; Use of Device Problem

  IT WAS REPORTED THAT DURING A PRIMARY PROCEDURE FOR A LEFT CALCANEUS FRACTURE, THAT HYDROSET XT (10 CC) ¿HARDENED SOLID¿ AFTER APPROXIMATELY 90 TO 105 SECONDS AND "A LOT" OF FORCE WAS NEEDED TO GET THE LIQUID OUT OF ITS CONTAINER AND INTO THE POWDER. THE PROCEDURE CALLED FOR A PLATE AND HYDROSET XT WAS INTENDED TO FILL ANY REMAINING CRACKS; HOWEVER, IT WAS DECIDED BY THE SURGEON TO DISCONTINUE USE OF HYDROSET XT DUE TO PREMATURE HARDENING OF THE COMPONENT. THIS RESULTED IN A SURGICAL DELAY OF 4-5 MINUTES. NO ADVERSE CONSEQUENCES TO THE PATIENT AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826120 ↗
• MalfunctionJul 25, 2019Use of Device Problem; Crack; Fracture; Use of Device Problem

  IT WAS REPORTED THAT DURING A PRIMARY PROCEDURE FOR A LEFT CALCANEUS FRACTURE, THAT HYDROSET XT (3 CC) ¿HARDENED SOLID¿ AFTER APPROXIMATELY 90 TO 105 SECONDS AND "A LOT" OF FORCE WAS NEEDED TO GET THE LIQUID OUT OF ITS CONTAINER AND INTO THE POWDER. THE PROCEDURE CALLED FOR A PLATE AND HYDROSET XT WAS INTENDED TO FILL ANY REMAINING CRACKS; HOWEVER, IT WAS DECIDED BY THE SURGEON TO DISCONTINUE USE OF HYDROSET XT DUE TO PREMATURE HARDENING OF THE COMPONENT. THIS RESULTED IN A SURGICAL DELAY OF 4-5 MINUTES. NO ADVERSE CONSEQUENCES TO THE PATIENT AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8826117 ↗
• MalfunctionJul 25, 2019Use of Device Problem; Use of Device Problem; Defective Device

  IT WAS REPORTED THAT DURING A PRIMARY PROCEDURE FOR A LEFT CALCANEUS FRACTURE, THAT HYDROSET XT (5 CC) ¿HARDENED SOLID¿ AFTER APPROXIMATELY 90 TO 105 SECONDS AND "A LOT" OF FORCE WAS NEEDED TO GET THE LIQUID OUT OF ITS CONTAINER AND INTO THE POWDER. THE PROCEDURE CALLED FOR A PLATE AND HYDROSET XT WAS INTENDED TO FILL ANY REMAINING CRACKS; HOWEVER, IT WAS DECIDED BY THE SURGEON TO DISCONTINUE USE OF HYDROSET XT DUE TO PREMATURE HARDENING OF THE COMPONENT. THIS RESULTED IN A SURGICAL DELAY OF 4-5 MINUTES. NO ADVERSE CONSEQUENCES TO THE PATIENT AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826116 ↗

Other Stryker Corporation products

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