SIGMA 1960-75-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295075493), received between Nov 6, 2017 and Mar 28, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LIGAMENTOUS INSTABILITY WITH NO LOOSENING. DOI: (B)(6) 2016; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13928585 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTED TOTAL KNEE. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED IN. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13177868 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REMOVAL OF ALL IMPLANTS DUE TO INFECTION, PRIMARY SURGERY WAS IN 2014 WITH A POLY EXCHANGE IN 2015. DOI: 2014-15, DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12505478 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FALL AND BROKE HIS MEDIAL CONDYL. NO DELAY TO SURGERY WAS REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 11634155 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS TO CAPTURE THE EVENT REPORTED IN (B)(4). ON (B)(6) 2017, THE PHYSICIAN ASPIRATED 16 ML FROM THE RIGHT KNEE TO RULE OUT INFECTION. THE PHYSICIAN INDICATED HE DID NOT THINK THE FLUID APPEARED INFECTED. THERE IS NO EVIDENCE OF REVISION FOLLOWING THE RIGHT QUADRICEP TENDON REPAIR. THERE IS NO EVIDENCE OF CONFIRMED INFECTION WITHIN THE AVAILABLE MEDICAL RECORDS. DOI: (B)(6) 2016, DOE: (B)(6) 2017, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11392286 ↗
• InjuryFeb 24, 2021Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT HAD TOTAL KNEE REPLACEMENT DONE ON (B)(6) 2016. HIS TOTAL KNEE REPLACEMENT IS GIVING HIM A PAIN FOR THE NEXT COUPLE OF YEARS AND HIS LOOKING TO FIND OUT WHAT ARE THE NEXT STEPS TO REMEDIATE. DUE TO HIS KNEE LOCKING UP, HE HAS FALLEN AND INJURED. ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY PRODUCTS WERE IMPLANTED WITH COMPETITOR CEMENT (STICKER SHEET FOUND ON PAGE 3 OF ATTACHED MEDICAL RECORDS). THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT KNEE REPAIR OF TORN QUADRICEP TENDON. PRIOR TO THE PROCEDURE, THE PATIENT WAS EXPERIENCING THE FOLLOWING ADVERSE SYMPTOMS: PAIN, INSTABILITY, EFFUSION, BRUISING TO KNEE, EDEMA, AND BLISTERS TO RIGHT FOOT MANAGED BY WOUND CARE. NO PRODUCTS WERE REMOVED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. FOLLOWING THE REPAIR OF RIGHT TORN QUADRICEP TENDON ON (B)(6) 2016, THE PATIENT CONTINUED TO EXPERIENCE PAIN. ON (B)(6) 2017, THE PHYSICIAN ASPIRATED 16 ML FROM THE RIGHT KNEE TO RULE OUT INFECTION. THE PHYSICIAN INDICATED HE DID NOT THINK THE FLUID APPEARED INFECTED. THERE IS NO EVIDENCE OF RE

  Patient problems: Blister; Ecchymosis; Fall; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11372802 ↗
• InjuryDec 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. IT WAS ALSO REPORTED THAT PATIENT HAD POLY EXCHANGE ON (B)(6) 2015. TIBIAL TRAY AND FEMUR DOI: (B)(6) 2013; DOR: (B)(6) 2017; RIGHT KNEE TIBIAL INSERT DOI: (B)(6) 2015.

  Patient problems: Pain

  MAUDE report 7120801 ↗
• InjuryNov 6, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIA AND FEMORAL COMPONENT AT CEMENT TO IMPLANT INTERFACE, CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 7005416 ↗