X-ChangeRecalls & reported problems across all models

We found 2 models of X-Change by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Nov 26, 2018 and Oct 9, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (2 reports).

1 FDA recall record 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

X-Change 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. Oct 3, 2019Terminated

   Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)

   Z-0514-2020 · Root cause: Employee error · Recall details · FDA record ↗

Most reported X-Change problems

X-Change models

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

• X-Change 0942-8-025

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  1 recall1 report
• X-Change 0942-8-050

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  1 report

Recent X-Change adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2019Packaging Problem; Packaging Problem

  THE CUSTOMER REPORTED THAT THE BOX FOR A 6 PETAL X-CHANGE MESH HAD A 4 PETAL IMPLANT IN THE BOX. UPDATE 23/09/2019: THERE WAS A SHORT DELAY OF AROUND 5 MINUTES WHILST THEY LOCATED AND OPENED ANOTHER PROSTHESIS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9173213 ↗
• MalfunctionNov 26, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE SEALING LINE(AREA) OF STERILE POUCH WAS DISCOLORED, IT WAS SEEMED DIRTY, THEREFORE IT WAS CHANGED TO OTHER ONE AND PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION RECEIVED: THE STORAGE CONDITIONS IN THE ROOM WHERE THE TEMPERATURE IS CONTROLLED, THE HUMIDITY ISN¿T CONTROLLED. THE STERILE BARRIER WAS SEEMED TO KEEP, BECAUSE THE SEALING LINE WASN¿T OPENED. DISCOLORATION SEEMED A BROWN. DEVICE WAS STORED OUT OF BOX.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8103886 ↗

Other Howmedica Osteonics Corp. products

• Triathlon608 models · 3,524 reports · 15 recalls
• Scorpio107 models · 113 reports · 28 recalls
• Trident160 models · 1,280 reports · 2 recalls
• Accolade57 models · 1,228 reports
• Duracon58 models · 65 reports · 16 recalls
• LFIT23 models · 852 reports
• TRIDENT II42 models · 188 reports · 12 recalls
• INSTRUMENT131 models · 290 reports · 7 recalls