SIGMA AOXRecalls & reported problems across all models

We found 53 models of SIGMA AOX by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 489 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2017 and Aug 17, 2026 — classified as 488 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (33 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SIGMA AOX problems

SIGMA AOX models

53 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SIGMA AOX 1961-92-031

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  39 reports
• SIGMA AOX 1961-92-042

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  38 reports
• SIGMA AOX 1961-92-032

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  32 reports
• SIGMA AOX 1961-92-041

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  31 reports
• SIGMA AOX 1961-92-021

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  28 reports
• SIGMA AOX 1961-92-022

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  22 reports
• SIGMA AOX 1961-92-051

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  22 reports
• SIGMA AOX 1961-92-052

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  21 reports
• SIGMA AOX 1961-92-011

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  20 reports
• SIGMA AOX 1961-92-043

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  17 reports
• SIGMA AOX 1961-92-151

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  16 reports
• SIGMA AOX 1961-92-033

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  14 reports
• SIGMA AOX 1961-92-132

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  13 reports
• SIGMA AOX 1961-92-141

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  13 reports
• SIGMA AOX 1961-92-053

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  12 reports
• SIGMA AOX 1961-92-133

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  11 reports
• SIGMA AOX 1961-92-044

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  9 reports
• SIGMA AOX 1961-92-131

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  9 reports
• SIGMA AOX 1961-92-034

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  8 reports
• SIGMA AOX 1961-92-122

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  8 reports
• SIGMA AOX 1961-92-121

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  7 reports
• SIGMA AOX 1961-92-124

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  7 reports
• SIGMA AOX 1961-92-142

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  7 reports
• SIGMA AOX 1961-92-145

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  7 reports
• SIGMA AOX 1961-92-054

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  6 reports
• SIGMA AOX 1961-92-062

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  6 reports
• SIGMA AOX 1961-92-135

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  6 reports
• SIGMA AOX 1961-92-153

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  6 reports
• SIGMA AOX 1961-92-161

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  5 reports
• SIGMA AOX 1961-92-023

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  4 reports
• SIGMA AOX 1961-92-144

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  4 reports
• SIGMA AOX 1961-92-152

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  4 reports
• SIGMA AOX 1961-92-024

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  3 reports
• SIGMA AOX 1961-92-126

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  3 reports
• SIGMA AOX 1961-92-143

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  3 reports
• SIGMA AOX 1961-92-010

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  2 reports
• SIGMA AOX 1961-92-012

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  2 reports
• SIGMA AOX 1961-92-113

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  2 reports
• SIGMA AOX 1961-92-116

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  2 reports
• SIGMA AOX 1961-92-134

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  2 reports
• SIGMA AOX 1961-92-146

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  2 reports
• SIGMA AOX 1961-92-147

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  2 reports
• SIGMA AOX 1961-92-154

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  2 reports
• SIGMA AOX 1961-92-155

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  2 reports
• SIGMA AOX 1961-92-157

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  2 reports
• SIGMA AOX 1961-92-013

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  1 report
• SIGMA AOX 1961-92-061

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  1 report
• SIGMA AOX 1961-92-063

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  1 report
• SIGMA AOX 1961-92-111

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  1 report
• SIGMA AOX 1961-92-123

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  1 report
• SIGMA AOX 1961-92-136

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  1 report
• SIGMA AOX 1961-92-156

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  1 report
• SIGMA AOX 1961-92-162

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  1 report

Recent SIGMA AOX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient had infected knee. Washout I&D. Poly was swapped from a 5x17.5 RP CVD to 5x20 RPPS. The post was shaved off the RPPS insert by Dr to fit with a CR Femur.Affected side-Right.

  Patient problems: Unspecified Infection

  MAUDE report 50275699 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that SIG RP AOX STB INS SZ5 20 was associated with an infected total knee. The insert had been implanted and was later removed during a revision procedure in which the poly was removed and irrigation and debridement were performed. Reported patient impact included a painful, swollen, infected knee, with infection, pain, edema, and device revision or replacement. Affected side: Right.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 50081747 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD BTK (B)(6) 2023, LEFT KNEE BECAME UNSTABLE, NO PROBLEMS W IMPLANTS/CEMENT, JUST GENERAL INSTABILITY, FIXED TODAY BY EXCHANGING 10MM POLY TO 15 MM POLY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25611146 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ANTERIOR KNEE PAIN. DOI: (B)(6), 2017 DOR: (B)6), 2026 AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 25084196 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD TIBIAL REVISION FOR PROXIMAL TIBIAL BONE LOSS. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Bone Notching

  MAUDE report 24875725 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY SWAP DUE TO INFECTION. DOI: ON (B)(6) 2019, DOR: ON (B)(6) 2026, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24858830 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD POLY EXCHANGE FOR PAIN. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24816037 ↗
• InjuryMar 26, 2026Naturally Worn

  IT WAS REPORTED THAT PATIENT HAD KNEE DISCOMFORT. POLY WAS WORN POSTERIOR LATERAL. PATELLA AND POLY WERE EXCHANGED. POLY WENT FROM 5 X 10 TO 5 X 12.5. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Discomfort

  MAUDE report 24702071 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD BILATERAL KNEE INFECTION. BOTH SIDES WERE SWAPPED OUT FOR NEW POLY. ON THE RIGHT SIDE, THERE WERE NO 3X17.5 RP CVD POLY AVAILABLE DUE TO BACK ORDER. THE POST WAS SHAVED OFF A 3X17.5 RPPS TO REPLICATE A CVD POLY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24364540 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD BILATERAL KNEE INFECTION. BOTH SIDES WERE SWAPPED OUT FOR NEW POLY. ON THE RIGHT SIDE, THERE WERE NO 3X17.5 RP CVD POLY AVAILABLE DUE TO BACK ORDER. THE POST WAS SHAVED OFF A 3X17.5 RPPS TO REPLICATE A CVD POLY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24364440 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE PAIN. POLY WAS REVISED FROM A 4X12.5 SIGMA RP CVD TO A 4X17.5. THE 17.5 WAS NOT AVAILABLE SO THE POST WAS SHAVED OFF OF A 4X17.5 RPPS. DOI: (B)(6) 2018, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24189835 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LIGAMENTOUS INSTABILITY. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085075 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LIGAMENTOUS INSTABILITY. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085074 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE ARE NO ADVERSE EFFECTS.

  Patient problems: Joint Laxity

  MAUDE report 24079853 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED DUE TO INFECTION. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24071902 ↗

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