GMK Primary Total Knee System 02.07.0512FUCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030818295), received between Jan 12, 2018 and Jun 28, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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 28, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 10 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT IMPLANTING A THICKER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 14839994 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP 7 YEARS AND 10 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10741024 ↗
• InjuryDec 6, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN 7 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY. THE SURGEON RESURFACED THE ORIGINAL PATELLA WITH ANOTHER COMPANY'S PRODUCT AND PERFORMED A POLY SWAP.

  Patient problems: Pain

  MAUDE report 8137077 ↗
• InjuryOct 26, 2018Microbial Contamination of Device

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 3 YEARS AND 4 MONTHS AFTER THE PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8008968 ↗
• InjuryMar 22, 2018Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018 MEDACTA US HAS BEEN INFORMED BY THE SALES AGENT THAT THE PATIENT CAME IN COMPLAINING OF PAIN. ON (B)(6) 2018 THE SURGEON SWAPPED THE POLY AS PLANNED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7362194 ↗
• InjuryJan 12, 2018Failure To Adhere Or Bond

  THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2016. IN (B)(6) 2016 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON SWAPPED THE INSERT ON (B)(6) 2016 (MDR (B)(4)) ON (B)(6) 2017 THE PATIENT WAS REVISED DUE TO FEELING LOOSE. THE CAUSE OF THE LAXITY WAS DUE TO THE SOFT TISSUE SWELLING GOING DOWN. THE SURGEON REVISED THE INSERT FROM A 12MM TO A 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7185283 ↗

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