SPECIALIST 86-5035Recalls & reported problems
Depuy (Ireland) · SPECIALIST PATELLAR CEMENTING CLAMP · Class 1
All models of SPECIALIST (80)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Specialist patellar clamp is a surgical clamp used in knee replacement surgery. Its 101 FDA reports include 1 injury and no deaths, and often describe breaks, jams, and locks that would not hold, with some reports of rust making clamps unusable. Reports rose to 6 in the last 12 months from 1 before. 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
- 101
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 10603295216605), received between Jul 18, 2017 and May 14, 2026 — classified as 1 injury, 100 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break32
- Device-Device Incompatibility17
- Mechanical Jam10
- Structural Problem10
- Naturally Worn9
- Appropriate Device Problem Term/Code Not Available6
- Detachment of Device or Device Component5
- Difficult to Open or Close5
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- No Consequences Or Impact To Patient40
- No Code Available5
- No Information5
- Not Applicable5
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Material Deformation
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE THE ACETABULAR REAMER WAS BENT, CAUSING UNEVEN REAMING OF THE ACETABULUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175302 ↗MalfunctionMay 14, 2026Corroded
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, THE PATELLAR CLAMPS WERE DEEMED UNSERVICEABLE BY HOSPITAL STERILE PROCESSING DUE TO RUST IN BETWEEN THE CUTTING GUIDE SLOT ON PATELLAR CLAMP. THE CLAMPS WERE OPENED AND REJECTED FROM THE STERILE FIELD DUE TO RUST, THIS CONSIDERED CONTAMINATED. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174111 ↗MalfunctionMay 14, 2026Corroded
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, THE PATELLAR CLAMPS WERE DEEMED UNSERVICEABLE BY HOSPITAL STERILE PROCESSING DUE TO RUST IN BETWEEN THE CUTTING GUIDE SLOT ON PATELLAR CLAMP. THE CLAMPS WERE OPENED AND REJECTED FROM THE STERILE FIELD DUE TO RUST, THIS CONSIDERED CONTAMINATED. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25173749 ↗MalfunctionMay 14, 2026Corroded
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, THE PATELLAR CLAMPS WERE DEEMED UNSERVICEABLE BY HOSPITAL STERILE PROCESSING DUE TO RUST IN BETWEEN THE CUTTING GUIDE SLOT ON PATELLAR CLAMP. THE CLAMPS WERE OPENED AND REJECTED FROM THE STERILE FIELD DUE TO RUST, THIS CONSIDERED CONTAMINATED. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25173748 ↗MalfunctionMar 5, 2026Structural Problem
IT WAS REPORTED THAT THE CLAMP WON'T LOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24517914 ↗MalfunctionFeb 12, 2026Detachment of Device or Device Component
ADDITIONAL INFORMATION STATES: CAN YOU PLEASE CLARIFY THE EXACT ALLEGATIONS AGAINST THE REPORTED PRODUCT? DID IT BREAK INTO TWO OR MORE PIECES? IS IT BENT, CRACKED, STRIPPED, DULL, WORN OR CROSS THREADED? MOST OF THEM HAVE JUST WEAR AND TEAR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321583 ↗MalfunctionApr 3, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE LOCKING MECHANISM WAS GETTING STUCK. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21763319 ↗MalfunctionOct 31, 2024Structural Problem; Structural Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATELLAR CLAMP LOCKING MECHANISM DOES NOT REMAIN ENGAGED WITHOUT CONTINUOUS PRESSURE BEING APPLIED. THE PRODUCT DAMAGE DOCUMENTED HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579399 ↗MalfunctionJun 21, 2024Break; Break
IT WAS REPORTED THAT THE PATELLA CLAMP WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19581053 ↗MalfunctionApr 25, 2024Corroded; Corroded
IT WAS REPORTED THAT THERE WAS RUST ON PFC PATELLAR CEMENTING CLAMP. NO INFLUENCE ON OR/PATIENT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19185354 ↗MalfunctionApr 9, 2024Structural Problem; Structural Problem
IT WAS REPORTED THAT THE PFC PATELLAR CEMENTING CLAMP CANNOT CLAMP ON TEETH WHEN PUT IN LOCK POSITION; CANNOT FUNCTION PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19070144 ↗MalfunctionFeb 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE LOAN SET WAS MISSING RUBBER O-RING FOR PATELLA CLAMP.SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18701683 ↗MalfunctionJan 18, 2024Difficult to Open or Close; Mechanical Jam; Naturally Worn; Difficult to Open or Close; Mechanical Jam; Naturally Worn
DAMAGED PATELLA CLAMP DUE TO WEAR AND TEAR, CLAMP WILL NOT OPEN, ITEMS NOT IN PIECES. LOT NUMBER UNKNOWN. NO DELAY TO SURGERY. NO IMPACT ON PATIENT. ITEMS NOT BEING SENT BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18534320 ↗MalfunctionJan 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT RED RUBBER PART IS MISSING FROM THE CLAMP. PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18454278 ↗MalfunctionDec 7, 2023Break; Break
TIBIAL IMPACTOR IS SHOWING SIGNS OF WEAR AND NEEDS REPLACING AND ALSO PATELLA CLAMP, THE RUBBER RING IS BROKE IN TWO PIECES ALL BITS RETRIEVED. NO DELAYS TO SURGERY OR HARM TO PATIENT. ITEMS N/A FOR RETURN AS HAVE BEEN DISPOSED OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18282153 ↗MalfunctionNov 27, 2023Mechanical Jam; Naturally Worn; Mechanical Jam; Naturally Worn
IT WAS REPORTED THAT THE CLAMP IS BROKEN DUE TO WEAR AND TEAR. MECHANISM JAMMED, NOT BROKEN IN TWO OR MORE PIECES. THERE WAS NO DELAY ON SURGERY, NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18208805 ↗MalfunctionNov 17, 2023Break; Break
IT WAS REPORTED THAT THE PATELLA CLAMPS BROKEN PLASTIC PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18161630 ↗MalfunctionNov 17, 2023Break; Break
IT WAS REPORTED THAT THE PATELLA CLAMPS BROKEN PLASTIC PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18161592 ↗MalfunctionOct 5, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION WAS RECEIVED. A. WAS THERE ANY SURGICAL DELAY? WHAT WAS THE DURATION OF THE DELAY? NO DELAY. B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO ADVERSE CONSEQUENCES. C. DID IT BREAK INTO 2 OR MORE PIECES? BROKE INTO 2 TOTAL PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17881077 ↗MalfunctionOct 3, 2023Break; Naturally Worn; Break; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE DEVICE WAS BROKEN INTO 2 PIECES. THE CHUNK CAME APART FROM IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17860017 ↗MalfunctionJun 9, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE PATELLA CLAMP HAD A DAMAGED ORANGE RING. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17099504 ↗MalfunctionApr 19, 2023Mechanical Jam; Naturally Worn; Mechanical Jam; Naturally Worn
IT WAS REPORTED THE CLAMP MECHANISM JAMMED AND NOT ABLE TO RELEASE. THE ISSUE IS LIKELY DUE TO WEAR AND TEAR. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16773892 ↗MalfunctionMar 10, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THE PATELLA CLAMP DOES NOT HOLD ONTO THE PATELLA. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16521875 ↗MalfunctionMar 1, 2023Break; Break
IT WAS REPORTED THAT THE DEVICE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16460762 ↗MalfunctionJan 26, 2023Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE PATELLA CLAMP BROKE DURING CEMENTING. CUT BLOCK BROKE UPON BEING MALLETED DOWN ON FEMUR. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16246393 ↗
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 96-6670Depuy Orthopaedics, Inc. · CLAMP92 reports
- ATRAUMATA FB469RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB461RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB738RAesculap AG · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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