P.F.C. SIGMA 96-0871Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA DISTAL AUGMENT COMBO SIZE 3 16mm LEFT · Class 3 · Implant
All models of P.F.C. SIGMA (487)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy P.F.C. Sigma distal augment is a metal component used to build up the lower part of a knee replacement. The 32 reports filed between January and February 2022 all describe problems found during repackaging and inspection: tears or holes in the sterile packaging and cosmetic marks on the part's top surface, with no patient harm reported. There were no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295234340), received between Jan 13, 2022 and Feb 24, 2022 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (32 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
Device problems
- Tear, Rip or Hole in Device Packaging32
Patient problems
- No Clinical Signs, Symptoms or Conditions32
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH OPERATOR WAS PERFORMING THE WI-0897 ¿REPACKAGING / RESTERILIZATION OF STERILE PRODUCT IN (B)(4)¿ FOR A PFC SIGMA AUGMENT REPACKAGING ORDER. DURING THIS PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. THE OPERATOR NOTIFIED THE FINISH LEAD, WHO CONTACTED PROCESS AND QUALITY ENGINEERING FOR FURTHER EVALUATION. THE IMAGE ATTACHED SHOWS A AUGMENT RETURNED FROM EXPIRY WITH FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS. THIS PC WAS CREATED TO CAPTURE THE PRODUCTS THAT ARE ALSO INVOLVE IN THE COMPLAINT REPORTED IN MAIN (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13592376 ↗MalfunctionFeb 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH OPERATOR WAS PERFORMING THE WI-0897 ¿REPACKAGING / RESTERILIZATION OF STERILE PRODUCT IN RAYNHAM¿ FOR A PFC SIGMA AUGMENT REPACKAGING ORDER. DURING THIS PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. THE OPERATOR NOTIFIED THE FINISH LEAD, WHO CONTACTED PROCESS AND QUALITY ENGINEERING FOR FURTHER EVALUATION. THE IMAGE ATTACHED SHOWS A AUGMENT RETURNED FROM EXPIRY WITH FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS. THIS PC WAS CREATED TO CAPTURE THE PRODUCTS THAT ARE ALSO INVOLVE IN THE COMPLAINT REPORTED IN MAIN (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13592375 ↗MalfunctionFeb 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH OPERATOR WAS PERFORMING THE WI-0897 ¿REPACKAGING / RESTERILIZATION OF STERILE PRODUCT IN RAYNHAM¿ FOR A PFC SIGMA AUGMENT REPACKAGING ORDER. DURING THIS PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. THE OPERATOR NOTIFIED THE FINISH LEAD, WHO CONTACTED PROCESS AND QUALITY ENGINEERING FOR FURTHER EVALUATION. THE IMAGE ATTACHED SHOWS A AUGMENT RETURNED FROM EXPIRY WITH FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS. THIS PC WAS CREATED TO CAPTURE THE PRODUCTS THAT ARE ALSO INVOLVE IN THE COMPLAINT REPORTED IN MAIN PC - (B)(4) AND (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13592373 ↗MalfunctionFeb 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH OPERATOR WAS PERFORMING THE WI-0897 ¿REPACKAGING / RESTERILIZATION OF STERILE PRODUCT IN RAYNHAM¿ FOR A PFC SIGMA AUGMENT REPACKAGING ORDER. DURING THIS PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. THE OPERATOR NOTIFIED THE FINISH LEAD, WHO CONTACTED PROCESS AND QUALITY ENGINEERING FOR FURTHER EVALUATION. THE IMAGE ATTACHED SHOWS A AUGMENT RETURNED FROM EXPIRY WITH FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS. THIS PC WAS CREATED TO CAPTURE THE PRODUCTS THAT ARE ALSO INVOLVE IN THE COMPLAINT REPORTED IN MAIN PC-(B)(4) AND (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13592372 ↗MalfunctionFeb 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH OPERATOR WAS PERFORMING THE WI-0897 ¿REPACKAGING / RESTERILIZATION OF STERILE PRODUCT IN RAYNHAM¿ FOR A PFC SIGMA AUGMENT REPACKAGING ORDER. DURING THIS PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. THE OPERATOR NOTIFIED THE FINISH LEAD, WHO CONTACTED PROCESS AND QUALITY ENGINEERING FOR FURTHER EVALUATION. THE IMAGE SHOWS A AUGMENT RETURNED FROM EXPIRY WITH FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS. THIS PC WAS CREATED TO CAPTURE THE PRODUCTS THAT ARE ALSO INVOLVE IN THE COMPLAINT REPORTED IN MAIN PC-(B)(4) AND (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13592370 ↗MalfunctionFeb 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH OPERATOR WAS PERFORMING THE WI-0897 ¿REPACKAGING / RESTERILIZATION OF STERILE PRODUCT IN RAYNHAM¿ FOR A PFC SIGMA AUGMENT REPACKAGING ORDER. DURING THIS PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. THE OPERATOR NOTIFIED THE FINISH LEAD, WHO CONTACTED PROCESS AND QUALITY ENGINEERING FOR FURTHER EVALUATION. THE IMAGE ATTACHED SHOWS A AUGMENT RETURNED FROM EXPIRY WITH FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS. THIS PC WAS CREATED TO CAPTURE THE PRODUCTS THAT ARE ALSO INVOLVE IN THE COMPLAINT REPORTED IN MAIN PC-(B)(4). AND (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13592368 ↗MalfunctionFeb 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH OPERATOR WAS PERFORMING THE WI-0897 ¿REPACKAGING / RESTERILIZATION OF STERILE PRODUCT IN RAYNHAM¿ FOR A PFC SIGMA AUGMENT REPACKAGING ORDER. DURING THIS PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. THE OPERATOR NOTIFIED THE FINISH LEAD, WHO CONTACTED PROCESS AND QUALITY ENGINEERING FOR FURTHER EVALUATION. THE IMAGE ATTACHED SHOWS A AUGMENT RETURNED FROM EXPIRY WITH FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS. THIS PC WAS CREATED TO CAPTURE THE PRODUCTS THAT ARE ALSO INVOLVE IN THE COMPLAINT REPORTED IN MAIN (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13592367 ↗MalfunctionFeb 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH OPERATOR WAS PERFORMING THE WI-0897 ¿REPACKAGING / RESTERILIZATION OF STERILE PRODUCT IN RAYNHAM¿ FOR A PFC SIGMA AUGMENT REPACKAGING ORDER. DURING THIS PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. THE OPERATOR NOTIFIED THE FINISH LEAD, WHO CONTACTED PROCESS AND QUALITY ENGINEERING FOR FURTHER EVALUATION. THE IMAGE ATTACHED SHOWS A AUGMENT RETURNED FROM EXPIRY WITH FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS. THIS PC WAS CREATED TO CAPTURE THE PRODUCTS THAT ARE ALSO INVOLVE IN THE COMPLAINT REPORTED IN MAIN (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13592365 ↗MalfunctionFeb 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH OPERATOR WAS PERFORMING THE WI-0897 ¿REPACKAGING / RESTERILIZATION OF STERILE PRODUCT IN RAYNHAM¿ FOR A PFC SIGMA AUGMENT REPACKAGING ORDER. DURING THIS PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. THE OPERATOR NOTIFIED THE FINISH LEAD, WHO CONTACTED PROCESS AND QUALITY ENGINEERING FOR FURTHER EVALUATION. THE IMAGE ATTACHED SHOWS A AUGMENT RETURNED FROM EXPIRY WITH FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS. THIS PC WAS CREATED TO CAPTURE THE PRODUCTS THAT ARE ALSO INVOLVE IN THE COMPLAINT REPORTED IN MAIN (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13592354 ↗MalfunctionJan 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13333951 ↗MalfunctionJan 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
B. IMPLANTS ARE AVAILABLE FOR RETURN. C. THE CORRECT LOT NUMBER IS E37AE4. I BELIEVE THESE PARTS HAVE BEEN RETURNED AND RECEIVED IN WARSAW. I HAVE REPLIED TO THIS SEVERAL TIMES. I AM NOT SURE WHY IT IS NOT REGISTERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13315250 ↗MalfunctionJan 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13315241 ↗MalfunctionJan 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13315226 ↗MalfunctionJan 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13315213 ↗MalfunctionJan 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13315197 ↗MalfunctionJan 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13315085 ↗MalfunctionJan 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13315042 ↗MalfunctionJan 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314850 ↗MalfunctionJan 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314817 ↗MalfunctionJan 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314811 ↗MalfunctionJan 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314723 ↗MalfunctionJan 13, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13256654 ↗MalfunctionJan 13, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13256652 ↗MalfunctionJan 13, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13256650 ↗MalfunctionJan 13, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE RESTERILIZATION AND REPACKAGING PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE OF THE PFC SIGMA AUGMENTS. THE AUGMENTS HAD FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13256647 ↗
Other Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing devices
- ATTUNE 1506-10-005Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing442 reports
- ATTUNE 1506-10-004Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing442 reports
- ATTUNE 1518-20-038Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing3 deaths393 reports
- LCS SIGMA 1294-33-130Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 recall310 reports
- ATTUNE 1518-20-035Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing342 reports
- P.F.C. SIGMA 96-0102Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 death319 reports
- ATTUNE 1518-20-041Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing308 reports
- ATTUNE 1506-10-007Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing284 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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