GMK Primary Total Knee System 02.07.0212FUCRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030816550), received between Dec 27, 2017 and Nov 25, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Unstable” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K090988); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2021Appropriate Device Problem Term/Code Not Available

  AT 8 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 12MM TO 17MM)AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12874255 ↗
• InjuryOct 30, 2019Unstable

  THE PATIENT CAME IN, 5 YEARS AND 8 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF INSTABILITY AND THE CAUSE OF INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE MEDACTA TIBIAL INSERT U.C. FIX S.2 / 12 MM WITH A MEDACTA INSERT U.C. 17MM S2. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9255104 ↗
• InjuryMar 21, 2019Unstable

  ABOUT 2 YEARS AFTER SURGERY THE SURGEON REVISED THE PATIENT KNEE FOR INSTABILITY. LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REASON OF THE INSTABILITY IS UNKNOWN.

  Patient problems: Joint Disorder

  MAUDE report 8439899 ↗
• InjuryJan 3, 2018Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE CAUSE OF INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE LINER FROM A 12MM TO A 20MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7160294 ↗
• InjuryDec 27, 2017Unstable

  IN 2017 THE PATIENT CAME IN FEELING UNSTABLE. THE CAUSE OF THE INSTABILITY IS UNKNOWN. ON (B)(6) 2017 THE SURGEON SWAPPED THE LINER FROM A 12MM TO A 17MM; SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7147255 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090988. One submission often covers many models, so check the product and lot details in each record.

• Z-0266-2018 · Oct 24, 2017 · Terminated
  The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0