ATTUNE 2545-01-042Recalls & reported problems
Depuy (Ireland) · ATTUNE PATELLA CLAMP RING · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune patella clamp ring is a surgical instrument used during knee replacement to hold the kneecap in place. Its 155 reports mostly describe rings breaking or cracking, parts wearing out, and the clamp not holding. The reports include no deaths and 2 injuries, and 153 are malfunctions. 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
- 153
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 10603295395454), received between Jul 21, 2017 and Aug 3, 2026 — classified as 2 injuries, 151 malfunctions.
The most frequently reported specific device problem is “Break” (75 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
- Break75
- Crack37
- Naturally Worn22
- Device-Device Incompatibility14
- Material Twisted/Bent9
- Detachment of Device or Device Component8
- Scratched Material7
- Appropriate Device Problem Term/Code Not Available6
Patient problems
- No Clinical Signs, Symptoms or Conditions89
- No Consequences Or Impact To Patient44
- Insufficient Information12
- No Information7
- No Code Available4
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114359 ↗MalfunctionAug 3, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114357 ↗MalfunctionJun 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE RUBBER RING OF PATELLA CLAMP FELL APART AFTER WASHING. THERE WERE NO ISSUES OR COMPLICATIONS. IT WAS REMOVED FROM SURGERY CENTER AFTER FALLING APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25411292 ↗MalfunctionMay 8, 2026Device-Device Incompatibility
IT WAS REPORTED THAT CLAMP WILL NOT HOLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25129956 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR THE HIP IT WAS OBSERVED THAT THE PINNACLE CUP IMPACTOR HANDLE BROKE WHILE IMPLANTING THE CUP. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE EXISTING INSTRUMENT. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955047 ↗MalfunctionMar 2, 2026Crack
IT WAS REPORTED THAT THE PATELLLA COMPRESSION RING HAS CRACKED IN THE POLY ORANGE RING PRONE TO INFECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24489492 ↗MalfunctionJan 13, 2026Device-Device Incompatibility
IT WAS REPORTED THAT PATELLA DRILL TRIALS WILL NOT STAY CONNECTED TO PATELLA DRILL CLAMP WHILE SIZING AND PREPPING THE PATELLA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053551 ↗MalfunctionNov 18, 2025Break; Break
IT WAS REPORTED THAT THE PATELLA RING BECAME SEVERELY CHIPPED DURING NORMAL STERILIZATION PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23587136 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT THE ORANGE RING WAS BROKEN IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513772 ↗MalfunctionOct 23, 2025Crack; Crack
IT WAS REPORTED THAT THE ORANGE RUBBER RING HAS CRACKS IN IT. REPLACEMENT IS NEEDED. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368407 ↗MalfunctionOct 21, 2025Break; Break
IT WAS REPORTED THAT THE RING WAS BROKEN. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351046 ↗MalfunctionJul 10, 2025Break; Break
IT WAS REPORTED THE RUBBER PIECE OF THE PATELLA CLAMP RING BROKE OFF. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469911 ↗MalfunctionJun 20, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 22301757 ↗MalfunctionApr 30, 2025Crack; Crack
IT WAS REPORTED THAT CSSD DISCOVERED HOLES IN TWO RED SILICONE DISCS. IT WAS ALSO DISCOVERED THAT AND RP IMPACTOR HAD WEAR AND CRACKS. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21937456 ↗MalfunctionApr 30, 2025Crack; Crack
IT WAS REPORTED THAT CSSD DISCOVERED HOLES IN TWO RED SILICONE DISCS. IT WAS ALSO DISCOVERED THAT AND RP IMPACTOR HAD WEAR AND CRACKS. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21937447 ↗MalfunctionApr 22, 2025Corroded; Corroded
IT WAS REPORTED THAT THE INSTRUMENT WERE PITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21880965 ↗MalfunctionFeb 20, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE RUBBER OF A PATELLA COMPRESSION RING HAS DEGRADED. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21424084 ↗MalfunctionJan 31, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEMS ARE NO LONGER ATTACHING TOGETHER, FOLLOWING STERILIZATION.THERE WAS NO HARM TO PATIENT AND NO DELAY TO SURGERY OCCURRED DUE TO EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21288735 ↗MalfunctionJan 27, 2025Break; Break
IT WAS REPORTED THAT THE RUBBER RING ON THE PATELLA CLAMP RING HAS A LITTLE CHIP MISSING. THIS WAS NOTICED WHILE SETTING UP THE ROOM. THERE WERE NO DELAYS, AND THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21243364 ↗MalfunctionJan 27, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT HAD THE ISSUE OF WEAR AND TEAR. RUBBER HAS RIPPED APART FROM THE INSTRUMENT. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21241229 ↗MalfunctionJan 6, 2025Break; Break
IT WAS REPORTED THAT THE HOSPITAL HAD FOUR TRAYS THAT WERE OUT OF ACTION WITH BROKEN INSTRUMENTS. THE ATTUNE PATELLA RING WAS TORN IN TWO PIECES. THE CEMENT RESTRICTOR INSERTER HAD FADED NUMBERS ON THE HANDLE. THE PINNACLE CUP IMPACTOR ROD THAT CONNECTS THE HANDLE WITH THE TIGHTENING KNOB WAS SPLIT IN TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078518 ↗MalfunctionJan 3, 2025Material Deformation; Material Deformation
IT WAS REPORTED ON (B)(6) 2024, IT FOUND DURING STERILIZATION INSPECTION THAT THE PATELLA CLAMP RUBBER RING IS TORN AND NEEDS REPLACING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21071576 ↗MalfunctionJan 2, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT THE DEVICE WAS REPORTED FOR WEAR AND TEAR. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057415 ↗MalfunctionDec 13, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING LOAN KIT INSPECTION IT WAS IDENTIFIED THAT THE INSTRUMENT, COMPOSED OF TWO PARTS, THE RUBBER SEAL HAS CRACKED AND IS FALLING APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20925066 ↗MalfunctionOct 23, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
SURGEON PLACED SCREW ONTO POWER TO INSERT INTO FEMORAL COMPONENT. WHEN ATTEMPTING TO PLACE SCREW INTO COMPONENT IT WAS CLEAR THERE WAS A BEND IN THE SCREW PREVENTING A STRAIGHT ENTRY POINT. NO HARM TO THE PATIENT. CLAMP WAS DAMAGED POST CASE. NO DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20513467 ↗
Other INSTRUMENT, COMPRESSION devices
- ATTUNE 2545-11-041Depuy (Ireland) · INSTRUMENT, COMPRESSION78 reports
- ATTUNE 2545-05-550Depuy (Ireland) · INSTRUMENT, COMPRESSION54 reports
- ATTUNE 2545-05-551Depuy (Ireland) · INSTRUMENT, COMPRESSION34 reports
- NA 03.111.021Synthes GmbH · INSTRUMENT, COMPRESSION32 reports
- ATTUNE 2545-05-552Depuy (Ireland) · INSTRUMENT, COMPRESSION27 reports
- NA 03.211.400Synthes GmbH · INSTRUMENT, COMPRESSION25 reports
- VIPER PRIME 286750083Medos International Sàrl · INSTRUMENT, COMPRESSION18 reports
- NA 03.111.022Synthes GmbH · INSTRUMENT, COMPRESSION17 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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