ATTUNE 1516-30-407Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295047643), received between Mar 29, 2019 and Jun 11, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Unintended Movement” (4 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED AND SURGEON DID A WASHOUT POLY EXCHANGE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25477640 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INSTABILITY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24790339 ↗
• InjuryAug 29, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ATTUNE CR-RP SPINOUT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17641683 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DEPUY SYNTHES JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AN IMPLANT SURGERY WAS PERFORMED VIA TKA FOR OA IN BOTH KNEES. ON (B)(6) 2023, THE PATIENT CAME TO THE HOSPITAL DUE TO SWELLING IN THE LEFT KNEE. THE REASON FOR THE INFECTION AND THE EVENT DATE ARE UNKNOWN. THE SURGERY FOR LEFT KNEE CLEANING IS SCHEDULED FOR (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 17397182 ↗
• InjuryMay 16, 2023Unintended Movement; Unintended Movement

  SURGEON PREFORMED TOTAL KNEE REPLACEMENT USING ATTUNE CEMENTLESS RP IMPLANTS. POST OP X-RAY SHOWED POST/LATERAL SPIN OUT. PATIENT WAS A FIXED VALGUS KNEE. SURGERY INCLUDED A POST LATERAL CAPSULE RELEASE WITH RESULT IN FLEXION INSTABILITY. POST OP X-RAY FOND THE INSERT HAD SPUN OUT POST/LATERAL. PATIENT WAS REVISED FROM A 7MM THICK INSERT TO A 16MM INSERT. PATIENT WAS REVISED ON A SAT WITH LIMITED STAFF AND THE STAFF COULDN¿T FIND THE 12MM AND 14MM THICK INSERTS.

  Patient problems: Joint Laxity

  MAUDE report 16937980 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS LOOSE IN EXTENSION AND FLEXION. GOING UP IN POLY THICKNESS. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16796228 ↗
• InjuryFeb 24, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA TKA FOR LEFT KNEE OA WITH THE INSERT 7MM IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. 1 WEEK AFTER THE SURGERY, THE INSERT IN QUESTION CAME OFF. ATTEMPTED MANUAL REDUCTION WAS UNSUCCESSFUL. ON (B)(6) 2023, THE REVISION SURGERY WAS DONE. AFTER INITIAL OPENING PROCEDURE, THE FOLLOWING CONDITIONS WERE OBSERVED. IT WAS CONFIRMED THAT THE INSERT HAD ROTATED 90°. HER LATERAL COLLATERAL LIGAMENT WAS LOOSE, AND THE TIBIAL ATTACHMENT OF THE PATELLAR LIGAMENT WAS FRACTURED AVULSION. THE TIBIAL ATTACHMENT OF THE PATELLAR LIGAMENT WAS REPAIRED WITH A HIGH-STRENGTH SUTURE. AS A RESULT OF TRIAL REDUCTION WITH AN INSERT TRIAL, THE TENDENCY TO PROLAPSE WAS SUBSIDED WITH AN INSERT OF 12 MM THICKNESS, SO A 12 MM THICK IMPLANT WAS RE-REPLACED. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AS THE CAUSE OF THIS EVENT AFTER PRIMARY SURGERY, IT IS POSSIBLE THAT THE FLEXION GAP WAS LOOSE DURING THE PRIMARY SURGERY, BUT THE SELECTION OF THE INSERT WITH A THIN 7MM MADE IT EASY TO COME OFF. IN ADDITION, THE PATIENT'S DELIRIUM PROGRESSED AFTER THE PRIMARY SURGERY,

  Patient problems: Bone Fracture(s); Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16436407 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A CR-TKA SURGERY FOR OA OF THE LEFT KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, ON (B)(6) 2022, WHEN THE PATIENT VISITED THE HOSPITAL DUE TO INSTABILITY OF THE KNEE, LOOSENESS OF THE KNEE JOINT WAS FOUND. THE PATIENT WAS CONSIDERED TO HAVE DEVELOPED LOOSENING OF THE KNEE JOINT DUE TO DYSFUNCTION OF THE POSTERIOR CRUCIATE LIGAMENT, AND A RE-OPERATION WAS SCHEDULED FOR (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2022- INSTABILITY. DOR2: (B)(6) 2022-LOOSENING. LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16052328 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2017. DATE OF EVENT: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15751216 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2017. DATE OF EVENT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2022. RIGHT KNEE. TREATMENT: REMOVAL OF FEMORAL COMPONENT, TIBIAL BASE, AND TIBIAL INSERT.

  Patient problems: Joint Laxity

  MAUDE report 14929608 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AFTER PRIMARY KNEE SURGERY ON (B)(6) AND SPLIT OPEN INCISION. SURGEON THEN DID A REVISION I&D, REMOVING IMPLANTS (FEMUR, TIBIA, INSERT), IRRIGATING THE WOUND, AND REPLACING WITH NEW CEMENTED IMPLANTS. PATELLA IMPLANT WAS RETAINED. NO DEFICIENCIES WERE NOTED WITH IMPLANTS. NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 12406290 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1. PLEASE CONFIRM IF THERE WAS ANY INDICATION THAT THE PATIENT'S KNEE WAS UNSTABLE PRIOR TO THE REVISION SURGERY? ANSWER: NO INDICATION OF INSTABILITY PRIOR TO FALL. 2. WAS THERE ANY ADVERSE CONSEQUENCES DUE TO FALL? ANSWER: THE KNEE BECAME UNSTABLE AFTER THE FALL SO HAVE TO ASSUME IT WAS FROM THE FALL. 3. WAS THERE A PREVIOUS REVISION INVOLVING EXPLANATION OF DEPUY PRODUCTS? ANSWER: NO PREVIOUS REVISION. 4. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? ANSWER: NOT RELATED TO POLY WEAR. POLY LOOKED GOOD. 5. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? ANSWER: NO MALPOSITIONING. 6. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? ANSWER: NO UNDER SIZING. 7. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? ANSWER: NO OVER RESECTION. 8. PLEASE CONFIRM IF THERE WAS ANY INDICATION THAT THE PATIENT'S KNEE WAS UNSTABLE PRIOR TO THE REVISION SURGERY? ANSWER: IT IS ASSUMED THE INSTABILITY HAPPENED FROM THE FALL. 9. A. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? A. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? C. WERE ANY CO

  Patient problems: Fall; Joint Laxity

  MAUDE report 11148630 ↗
• InjuryMay 6, 2020Unintended Movement; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE SURGEON COMMENTED THAT THE SPIN-OUT WHICH OCCURRED 2 WEEKS AFTER THE PRIMARY SURGERY WAS CAUSED BY BAD BALANCE OF EXTENSION AND FLEXING, IT WAS A TECHNICAL ERROR.

  Patient problems: No Code Available

  MAUDE report 10030545 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR LEFT TOTAL KNEE REVISION TO ADDRESS INSTABILITY DATE OF IMPLANTATION: UNKNOWN. DATE OF REVISION: (B)(6) 2019, (LEFT KNEE). WERE DEPUY COMPONENTS REMOVED: YES.

  Patient problems: No Code Available

  MAUDE report 9592645 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. FEMORAL COMPONENT WAS REVISED. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9341049 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE CEMENTLESS IMPLANTS WERE REMOVED BECAUSE OF INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8571432 ↗
• InjuryMar 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STICKER SHEET PROVIDED WITH ATTUNE IMPLANTS INDICATING PATIENT UNDERWENT A RIGHT TKA ON (B)(6) 2017. SHE THEN UNDERWENT A REVISION ON (B)(6) 2018 FOR PAIN AND FEELINGS OF INSTABILITY WHEN WALKING OR RISING FROM A CHAIR. THE SURGEON NOTES NO SIGNS OF INFECTION, WEAR OR LOOSENING DURING OPERATION. POLY INSERT WAS SWITCHED OUT FROM A 7MM TO 12MM ACHIEVING IMPROVED STABILITY. DOI: (B)(6) 2017; DOR: (B)(6) 2018; (INSERT ONLY).

  Patient problems: Pain

  MAUDE report 8465517 ↗