GMK Primary Total Knee System 02.07.0512PSFRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030818325), received between Feb 11, 2020 and Jun 3, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14591442 ↗
• InjuryFeb 22, 2022Fracture; Fracture

  THE PATIENT HAD A PRIMARY TKR ON (B)(6) 2011. ON THE (B)(6) 2013 THE PATIENT HAD A REVISION SURGERY WITH LINER SWAP, THE REASON OF THIS REVISION IS UNKNOWN. AT 8 YEARS AND 8 MONTHS FORM THE FIRST REVISION THE PATIENT HAD A NEW REVISION SURGERY FOR LINER FIXATION SCREW BREAKAGE. THE SURGEON SWAPPED SUCCESSFULLY THE PATIENT TIBIAL TRAY AND LINER. THE PATIENT HAD A FELL ON HIS KNEE ON (B)(6) 2018.

  Patient problems: Insufficient Information

  MAUDE report 13575834 ↗
• InjuryNov 25, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12874310 ↗
• InjuryJan 7, 2021Loosening of Implant Not Related to Bone-Ingrowth

  RIGHT KNEE GMK PRIMARY INLAY CHANGE FROM 12MM TO 17MM AND PATELLA IMPLANT INSTALLATION AFTER 4 YEARS AND 8 MONTHS FROM THE PRIMARY(6 APR 2016) SURGERY DUE TO KNEE INSTABILITY. LEFT KNEE GMK SPHERE INLAY CHANGE FROM 12MM TO 17MM AFTER 1 YEAR AND 8 MONTHS FROM THE PRIMARY(15 MAY 2019) SURGERY DUE TO KNEE INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 11130578 ↗
• InjuryJun 12, 2020Appropriate Device Problem Term/Code Not Available

  WASH-OUT AND POLYSWAP PERFORMED 8 MONTHS AFTER PRIMARY DUE TO AN INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10147231 ↗
• InjuryFeb 11, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO ANTERIOR KNEE PAIN, 4 YEARS AFTER PRIMARY. THE INLAY HAS BEEN CHANGED WITH 14 MM INLAY AND PATELLA RESURFACING HAS BEEN PERFORMED.

  Patient problems: Pain

  MAUDE report 9693399 ↗

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