P.F.C. SIGMA 96-2022Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295240686), received between Nov 2, 2017 and Sep 23, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Naturally Worn” (8 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED: ON (B)(6) 2024, MEDICAL RECORDS NOTED THE PATIENT IS 6 WEEKS POST HIP ARTHROPLASTY. IT WAS SAID THAT THE PATIENT HAD A CT SCAN TWO WEEKS AGO AND IT SHOWED A PULMONARY EMBOLISM. THE PATIENT WAS PRESCRIBED ELIQUIS MEDICATION AND OVERALL IS DOING WELL. ON (B)(6) 2024, THE PATIENT IS NOW 3 ½ MONTHS OUT FROM A RIGHT TOTAL HIP IT WAS NOTED THAT THE PATIENT HAD A PE AFTERWARDS. DEPUY STEM AND CUP ARE REPORTED TO BE WELL PLACED ON A RADIOGRAPH.

  Patient problems: Pulmonary Embolism

  MAUDE report 20280880 ↗
• InjuryOct 4, 2023Naturally Worn; Naturally Worn

  PATIENT, HAD PRIMARY KNEE REPLACEMENT SOMEWHERE IN SOUTH AFRICA. REASON FOR REVISION WAS DUE TO POLYETHYLENE WEAR. THE IMPLANTS APPEARED TO BE WELL FIXED IN THE X-RAY, SO, DUE TO HER AGE, PLAN A WAS TO JUST EXCHANGE THE POLYETHYLENE INSERT, AS LONG AS WE HAD THE APPROPRIATE IMPLANT AND SIZE. THERE IS NO PAPER TRAIL SO REQUIRED US TO INTERPRET THE X-RAY WHICH WE BELIEVED TO BE A SIGMA CR ROTATING PLATFORM. SHOULD WE NOT HAVE THE APPROPRIATE IMPLANT THEN THE PLAN WAS TO REMOVE ALL THE KNEE COMPONENTS AND REPLACE WITH ATTUNE REVISION. ONCE EXPOSURE WAS GAINED AND THE INSERT WAS REMOVED WE COULD TELL THAT IT WAS A SIZE 2.5 12.5MM CR INSERT, WE WERE ABLE TO UPSIZE TO 15MM, KNEE WAS THEN REDUCED AND WAS VERY STABLE.

  Patient problems: Joint Laxity

  MAUDE report 17871181 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15914856 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D WITH POLY EXCHANGE WAS DONE. THE PATIENT HAD 90,000 WHITE COUNT, LABS NOT BACK YET TO CONFIRM INFECTION. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15691370 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE REVISION FOR PAIN DUE TO IMPLANTS OVERSIZE. CEMENT NOT FROM DEPUY. DOI: (B)(6) 2009; DOR: (B)(6) 2022; UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 15417145 ↗
• InjuryJul 25, 2022Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE - REVISED TO A 17.5 POLY THICKNESS. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 15093864 ↗
• InjuryApr 19, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE POSTERIOR PART OF THE POLY WAS WORN, IN BOTH MEDIAL AND LATERAL SIDES. SURGERY TIME WAS NOT EXTENDED.

  Patient problems: Joint Laxity

  MAUDE report 11691216 ↗
• InjuryFeb 24, 2021Unintended Movement; Unintended Movement

  THE PATIENT'S KNEE WAS REVISED DUE TO RP POLY INSERT WAS SPINNING OUT. FEMUR, TIBIAL TRAY, AND TIBIAL INSERT REVISED WITH REV ATTUNE COMPONENT. NO SURGICAL DELAY REPORTED. DOI: UNK, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11373447 ↗
• InjuryNov 18, 2019Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO AN INSTABILITY WITH SEVERE POSTERIOR MEDIAL WEAR ON TIBIAL INSERT. DOI: (B)(6) 2006; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9336581 ↗
• InjuryMar 5, 2019Naturally Worn; Naturally Worn

  16 YRS POST IMPLANTATION, REMOVAL OF POLYETHYLENE POLYETHYLENE INSERT WORN ON POSTERIOR MEDIAL SIDE.

  Patient problems: No Code Available

  MAUDE report 8390322 ↗
• InjuryJan 28, 2019Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Code Available

  MAUDE report 8281065 ↗
• InjuryMay 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION WITH DRAINING SINUS. I&D AND POLY INSERT WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7556588 ↗
• InjuryNov 21, 2017Naturally Worn; Naturally Worn

  DER STATES THAT THE PATIENT COMPLAINED OF DISCOMFORT. REVISED FOR ECCENTRIC POLY WEAR. IT WAS ALSO STATED THAT THE POLY WAS IN GOOD CONDITION WITH NO SIGNS OF OXIDATION BUT DID EXHIBIT EVIDENCE OF WEAR ON THE MEDIAL ASPECT.

  Patient problems: Discomfort

  MAUDE report 7050244 ↗
• InjuryNov 2, 2017Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INNER PART OF THE INSERT WAS WORN OUT AND THE FEMUR WAS DISLOCATED OUTWARD WHERE THE INSERT WAS 90 DEGREES TURNED.

  Patient problems: No Code Available

  MAUDE report 6998463 ↗