ATTUNE 1516-50-812Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295052890), received between Jul 21, 2017 and May 21, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D POLY EXCHANGE WAS DONE FOR INFECTION STAPH EPIDERMAIDUS. POLY WAS REPLACED WITH SAME SIZE. THERE WERE NO OTHER ISSUES WITH IMPLANTS. AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22059383 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT ON VACATION SHORTLY AFTER A PROCEDURE AND DEVELOPED AN INFECTION. SURGEON SWAPPED THE POLY AND PERFORMED A WASH OUT. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21730406 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED STRYKER PATELLA FOR EFFUSIONS CHANGED OUTLOOK TO A CRS WHILE IN THE KNEE. IT WAS A STRYKER PATELLA ISSUE. DOI: UNK. DOR: (B)(6) 2025. AFFECTED SIDE: UNK KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 21514102 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RIGHT KNEE WAS A LITTLE TIGHT. SURGEON OPENED THE KNEE AND DID A REMOVAL OF SOFT TISSUE AND POLY SWAP TO A SMALLER SIZE ON (B)(6) 2024. SURGEON STATED NOTHING LOOKED WRONG WITH THE IMPLANTS AND THOUGHT THE PATIENT HAD GOOD ROM AFTER THE POLY SWAP. THERE WAS NO SURGICAL DELAY. ORIGINAL IMPLANT DATE WAS (B)(6) 2018.

  Patient problems: Muscular Rigidity

  MAUDE report 20418584 ↗
• InjuryJul 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF FEMORAL COMPONENTS OF ATTUNE REVISION POST DISLOCATION TO SROM HINGE.

  Patient problems: Joint Dislocation

  MAUDE report 19666577 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL ATTUNE KNEE DONE. THE PATIENT WAS INFECTED, SO ALL COMPONENTS WERE REMOVED AND TEMPORARY PARTS IMPLANTED. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19593223 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SWAPPED FROM PS POLY TO CRS POLY FOR MORE STABILITY. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18888016 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS KNEE WAS INFECTED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOR-(B)(6) 2024 AFFECTED SIDE- LEFT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 18836391 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WITH PREVIOUS ATTUNE KNEE REVISION WAS REVISED DUE TO LIGAMENT LAXITY. WELL FIXED ATTUNE REVISION IMPLANTS REMOVED AND REPLACED WITH A HINGE BEARING. DID THE EVENT OCCUR DURING STERILE PROCESSING? NO, DID THE EVENT OCCUR DURING FIELD INSPECTION? NO, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PATIENT WITH PREVIOUS ATTUNE KNEE REVISION WAS REVISED DUE TO LIGAMENT LAXITY. WELL FIXED ATTUNE REVISION IMPLANTS REMOVED AND REPLACED WITH A HINGE BEARING, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE PATIENT WITH PREVIOUS ATTUNE KNEE REVISION WAS REVISED DUE TO LIGAMENT LAXITY. WELL FIXED ATTUNE REVISION IMPLANTS REMOVED AND REPLACED WITH A HINGE BEARING., IS THE PATIENT PART OF A CLINICAL STUDY: NO, IP-01591291 DEVICE PROPERTY OF : NONE, DEVICE IN POSSESSION OF : NONE, IP-01591292 DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-01591293 DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NO

  Patient problems: Joint Laxity

  MAUDE report 15951151 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND STIFFNESS WITH LIMITED MOTION. THE SURGEON DOWNSIZED THE TIBIAL INSERT AND THE MOTION IS GOOD NOW. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 15672927 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15411486 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. UNKNOWN PRIMARY DATE. POLY REVISION ON (B)(6) 2019. SURGEON REMOVED POLY AND PS FEMUR AND REPLACE WITH A CRS FEMUR WITH A STEM AND A CRS INSERT TO HELP CORRECT PATIENT INSTABILITY. NO SURGICAL DELAY. DOI: UNKNOWN, DOI: (B)(6) 2019 - (POLY EXCHANGED), DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11012041 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE BECAME INFECTED. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10774607 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS A RUPTURED INCISION DUE TO FALL. A POLY EXCHANGE WAS DONE TO PREVENT INFECTION. DOI: (B)(6) 2020 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 10281370 ↗
• InjuryNov 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. IT ALSO REPORTED THAT THEY DID POLY SWAP.

  Patient problems: Unspecified Infection

  MAUDE report 7052037 ↗
• InjuryJul 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS POTENTIAL INFECTION AND PAIN.

  Patient problems: Pain

  MAUDE report 6731579 ↗