ATTUNE 1516-20-308Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295045434), received between Jun 4, 2019 and Dec 2, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (1 report).

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER SIX MONTHS OF REHAB THE PATIENT FAILED TO CREATED ADEQUATE FLEXION AND EXTENSION. A THINNER POLY WAS IMPLANTED AND FULL MOTION IS RESTORED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 20824388 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS TO CAPTURE THE 1 X REVISION MENTIONED IN INSTRUMENT COMPLAINT (B)(4) CONFIRMED AS REVISION OF DEPUY PRODUCTS VIA RESPONSE TO "REQUEST FOR ADDITIONAL INFORMATION". INITIAL OPERATION 2018: IN THE PATIENTS NOTES FROM THE ORIGINAL OPERATION THE SURGEON COMMENTED THAT AFTER THE CUTS THE KNEE REMAINED WITH ¿GROSS TIGHTNESS¿ ON THE LATERAL SIDE. HE DOWN SIZED THE FEMUR FORM A SIZE 4 TO A SIZE 3 AND INTERNALLY ROTATED THE FEMORAL CUTS SLIGHTLY TO EASE THE TIGHTNESS. THIS WORKED TO SOME EXTENT BUT TIGHTNESS DID REMAIN. THE SURGEON DID NOT FEEL THAT THE RESIDUAL TIGHTNESS WARRANTED SOFT-TISSUE RELEASE. ACCORDING TO THE REVISION SURGEON THE PATIENT HAD EXPERIENCED POST OP PAIN AND TIGHTNESS FOR QUITE SOME TIME. THIS WAS NOT RESOLVED THROUGH PHYSIO AND EXERCISE. SO THE DECISION WAS MADE TO REVISE THE KNEE WITH THE AIM OF REDUCING PAIN AND TIGHTNESS NO BATCH NUMBERS WERE OBTAINED FROM THE EXPLANTED PROSTHESIS. THIS WAS NOT POSSIBLE DUE TO CEMENT AND TISSUE DEBRIS (THE SECOND REVISION CASE MENTIONED IN (B)(4) DID NOT INVOLVE DEPUY SYNTHES IMPLANTS).

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 13938491 ↗
• MalfunctionMar 17, 2022Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN EXPIRED PRODUCT. PRODUCT RECEIVED ON 03/01/2022 WHEREAS THE DEVICE WAS EXPIRED SINCE 02/28/2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13800739 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT ATTUNE TKR, WASHOUT, DEBRIDEMENT AND EXCHANGE OF POLY INSERT. PATIENT UNDERWENT PRIMARY ATTUNE TKR ON (B)(6) 2020. SUSPECTED INFECTION ON (B)(6) 2020. UPON OPENING THE KNEE A LARGE AMOUNT OF HAEMATOMA WAS PRESENT, THIS WAS REMOVED., THE KNEE WAS WASHED OUT AND THE POLY INSERT EXCHANGED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma

  MAUDE report 10935439 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 15 OCTOBER 2019 FOR MDR REPORTABILITY. ON UNKNOWN DATE, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO UNKNOWN DIAGNOSES. THERE WAS NO HISTORY, NOR OPERATIVE NOTES INCLUDED IN THE PATIENT¿S MEDICAL INFORMATION. A STICKER PAGE LOCATED ON PAGE 12/13, INDICATED THE PATIENT HAD BEEN IMPLANTED WITH ATTUNE COMPONENTS AND COMPETITOR CEMENT IN THE PRIMARY OPERATION. ON (B)(6) 2015, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN AND FLEXION INSTABILITY. THE SURGEON OFFERED NO CONCERNS WITH ANY OF THE IMPLANTED COMPONENTS. THE TIBIAL AND THE FEMORAL COMPONENTS WERE REVISED. THE PATELLAR COMPONENT WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: UNKNOWN, DOR: (B)(6) 2015 (RT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9291493 ↗
• InjuryJun 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN, POOR MOTION AND SUSPECTED LOOSE ATTUNE KNEE. BONE SCAN "LIT-UP" ON THE FEMORAL COMPONENT. KNEE WAS NOT FOUND TO BE LOOSE. INSERT WAS DOWNSIZED FROM AN 8MM THICK TO A 7MM. SCAR TISSUE WAS REMOVED. DOI: (B)(6) 2013; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Loss of Range of Motion; No Code Available; Pain; Scar Tissue

  MAUDE report 8666736 ↗