P.F.C. SIGMA 96-6683Recalls & reported problems
Depuy Orthopaedics, Inc. · P.F.C. SIGMA INSET PATELLAR - CEMENTING CLAMP HEAD · Class 1
All models of P.F.C. SIGMA (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295249610), received between Oct 4, 2017 and Dec 18, 2025 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (12 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility12
- Break2
- Appropriate Device Problem Term/Code Not Available1
- Difficult to Remove1
- Naturally Worn1
- Separation Problem1
- Structural Problem1
Patient problems
- No Consequences Or Impact To Patient9
- No Clinical Signs, Symptoms or Conditions7
- No Information2
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA HEAD SLIDES OFF THE CLAMP BECAUSE THE JOINT HOLDING IT IN PLACE WAS WORN OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842793 ↗MalfunctionOct 30, 2024Structural Problem; Structural Problem
IT WAS REPORTED THAT THE BUTTON DOES NOT STAY ON CLAMP. THE EVENT DID NOT HAPPEN DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570372 ↗MalfunctionJun 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO SURGICAL DELAY AND THAT THE PATIENT DID NOT HAVE ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181472 ↗MalfunctionJun 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA CLAMP ATTACHMENT WON¿T STAY CONNECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181437 ↗MalfunctionJan 18, 2023Break; Break
THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16196205 ↗MalfunctionOct 10, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA CLAMP HEAD (ORANGE RING) NO LONGER CLAMPS INTO THE PATELLA CLAMP. BOTH PIECES ARE BEING RETURNED. NO ADVERSE AFFECTS ON THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15568679 ↗MalfunctionJan 22, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT AS THE INSTRUMENTS WERE BEING ASSEMBLED BEFORE THE CASE, IT WAS NOTICED THAT THE PATELLAR REAMER BODY WOULD NOT ACCEPT THE PIN AND BLADE FOR THE PLANER (PIN WOULD NOT SEAT). IN THE SAME TRAY, THE PATELLAR CLAMP HANDLE WOULD NOT HOLD THE PATELLAR CLAMP TIGHTLY AS IT WOULD NOT LOCK INTO PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11217658 ↗MalfunctionMar 9, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA CLAMP AND ADAPTER WILL NOT HOLD. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9807845 ↗MalfunctionMar 5, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA CLAMP AND ADAPTER WILL NOT HOLD. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9792439 ↗MalfunctionFeb 11, 2020Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility
IT WAS REPORTED THAT THE MODULAR PATELLA CLAMP WILL NO LONGER HOLD. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9693379 ↗MalfunctionFeb 7, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE MODULAR PATELLA CLAMP WILL NO LONGER HOLD. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9682450 ↗MalfunctionJun 18, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ORANGE RING MODULAR PIECE DOES NOT FULLY ENGAGE WITH THE CLAMP HANDLE. ALL PIECES WERE RETRIEVED AND NOTHING WAS MISSING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8708542 ↗MalfunctionJan 9, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA CLAMP WOULD NOT PROPERLY CONNECT TO THE PATELLA CLAMP ATTACHMENT. ATTACHMENT WOULD FALL WHEN TILTED INTO A DOWNWARD ANGLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8230825 ↗MalfunctionJan 8, 2019Separation Problem; Separation Problem
IT WAS REPORTED THAT THE PATELLA CLAMP ATTACHMENT FALLS OUT WHEN INSERTED AND CONNECTED TO THE PATELLA CLAMP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8226566 ↗MalfunctionNov 16, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SPRING FELL OUT OF THE CLAMP AND THE ORANGE MODULAR PIECE WILL NOT STAY IN THE HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8078256 ↗MalfunctionApr 12, 2018Naturally Worn; Naturally Worn
IT WAS REPORTED THAT WHEN CEMENTING PATELLA, THE TIP ON THE CLAMP WHICH RESTS ON THE ARTICULAR SURFACE OF PATELLA KEPT SLIPPING, MAKING IT DIFFICULT TO ADD ADEQUATE PRESSURE. RUBBER RING LOOKS WORN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7424588 ↗MalfunctionOct 25, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE IMPLANTATION ATTACHMENT WOULD NOT LOCK IN TO THE MODULAR PATELLA CLAMP. ANOTHER CLAMP WAS AVAILABLE AND THE SURGERY PROCEEDED AS PLANNED.
Patient problems: No Information
MAUDE report 6977552 ↗MalfunctionOct 4, 2017Break; Break
(B)(4) COMPLAINT FORM STATES THAT CSR REPORTED DAMAGE. THE PATELLA HAS A PIECE OF THE ORANGE RUBBER MISSING.
Patient problems: No Information
MAUDE report 6913476 ↗
Other CLAMP devices
- ATTUNE 2544-00-001Depuy (Ireland) · CLAMP144 reports
- NA 2178-63-134Depuy (Ireland) · CLAMP137 reports
- ATTUNE 2545-01-055Depuy (Ireland) · CLAMP128 reports
- SPECIALIST 86-5035Depuy (Ireland) · CLAMP101 reports
- SPECIALIST 96-6670Depuy Orthopaedics, Inc. · CLAMP92 reports
- ATRAUMATA FB469RAesculap AG · CLAMP1 recall0 reports
- Centurion I68080Centurion Medical Products Corporation · CLAMP1 recall0 reports
- ATRAUMATA FB459RAesculap AG · CLAMP1 recall0 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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