ATTUNE LPS 1517-60-212Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295490968), received between Oct 20, 2020 and Aug 11, 2026 — classified as 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 15, 2023Class IIOpen, Classified

   The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

   Z-1264-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

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

  It was reported that the doctor changed poly as the doctor performed an extensor mechanism repair.DOI: (b)(6)2025.DOR: (b)(6)2026.Affected side: Right.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50209266 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented post revision total knee arthroplasty with an improperly tracking patella. Femoral components was exchanged to a smaller femur, thus shortening overall the distance of the construct and creating less tension on her quadriceps mechanism. A lateral release was also performed in conjunction with an extensive repair or her medial tissues. This resulted in a better tracking patellar and should result in more proper function. LPS Adapter had been placed on (b)(6)2026 and LPS distal femur and insert had been placed on (b)(6)2026. No allegation was made against any component. The patella implant but was well fixed and left in place.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right knee.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50025126 ↗
• InjuryJun 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT LINER EXCHANGE DUE TO DISLOCATION. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 25382155 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED A HEMATOMA POST REV TKA. PATIENT WAS BROUGHT TO THE OR FOR AN I&D AND EVACUATION OF HEMATOMA. THERE WAS NO DELAY NOR PATIENT HARM NOTED. INSERT WAS EXCHANGED AND RESORBABLE ANTIBIOTIC BEADS WERE PLACED. ALL COMPONENTS WERE WELL FIXED AND WELL FUNCTIONING. NO ALLEGATION IS MADE AGAINST ANY COMPONENT. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 25116274 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED KNEE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25002207 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A DEHISCED KNEE FROM PREVIOUS SURGERY. PATIENT WAS WASHED OUT AND WOUND WAS REVISED. THE DOCTOR DECIDED TO REPLACE POLY DURING I&D OF THE JOINT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Wound Dehiscence

  MAUDE report 23817552 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND SURGEON ELECTED TO REMOVE IMPLANTS AND FUSE KNEE. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23369927 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. PARTS WERE REPLACED TO REDUCE BIOBURDEN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22649448 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21530241 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. THE SURGICAL DELAY IS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21410031 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PATELLA REVISION ON (B)(6) 24, 969 IN OPTIMIZE. UNFORTUNATELY, DUE TO SHEER SIZE OF HER LEG, THE PATIENT DEVELOPED A HEMATOMA POSTOPERATIVELY. PATIENT WAS BROUGHT TO THE OR FOR AN EXTENSIVE I&D AND EVACUATION OF HEMATOMA. THE SURGEON EXCHANGED THE INSERT AND PIN FROM THE LISTED SROM FEMUR AND PLACED RESORBABLE ANTIBIOTIC BEADS. CULTURES WERE TAKEN BUT RESULTS WILL NO BE AVAILABLE FOR A NUMBER OF DAYS. THERE WAS NO DELAY OR PATIENT HARM. THERE ARE NO ALLEGATIONS AGAINST ANY DEPUY PRODUCTS, SIMPLY EXCHANGED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 20191259 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO BE REINFECTED AFTER A 2-STAGE REVISION TKA. ALL COMPONENTS WERE REMOVED, AND A THOROUGH DEBRIDEMENT WAS PERFORMED. A SPACER WAS PLACED USING LPS COMPONENTS, INCLUDING THE PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND COATING THE PROSTHESIS WITH HIGH-DOSE ANTIBIOTIC CEMENT. NO DELAY OR PATIENT HARM WAS NOTED. THERE WAS NO ALLEGATION AGAINST ANY DEPUY COMPONENT; THEY WERE SIMPLY REMOVED DUE TO INFECTION. CEMENT WAS HOSPITAL-OWNED, SO LOT INFORMATION WAS UNAVAILABLE, BUT THE SURGEON'S ROUTINE INVOLVED USING DEPUY 2 WITH GENT FOR REVISION CASES. ALL PART AND LOT INFORMATION WAS COPIED AND PASTED DIRECTLY FROM OPTIMIZE AND WAS ACCURATE PER THAT SYSTEM. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19928223 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM. SURGEON INTENTIONALLY SHORTENED HER FEMORAL CONSTRUCT WHEN DOING SO TO ALLOW FOR INCREASED FLEXION. PATIENT FELT UNSTABLE AND WAS BROUGHT TO THE OR FOR INCREASED LENGTH. COMPONENTS WERE EXCHANGED WITHOUT DELAY OR PATIENT HARM. THERE ARE NO ALLEGATIONS AGAINST ANY COMPONENTS, ONLY FILING DUE TO THE EXCHANGE OF COMPONENTS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19906777 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DRAINAGE POST SURGERY AND ELEVATED LABS INDICATIVE OF INFECTION. COMPONENTS WERE REMOVED AND A SPACER WAS MADE UTILIZING LPS COMPONENTS. NO DELAY WAS EXPERIENCED NOR PATIENT HARM OCCURRED. DOI: ON (B)(6) 2022. DOR: ON (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19828685 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINT PAIN AND LACK OF MOTION. SURGEON WENT IN AND FOUND THE COMPONENTS WELL FIXED. HE REMOVED THE INSERT AND PERFORMED AN I&D. SURGEON FELT THE FEM COMPONENT WAS PLACED IN TOO MUCH FLEXION. THE COMPONENT WAS REMOVED AND A NEW FEMORAL COMPONENT AND INSERT WAS INSERTED. THE TIBIAL COMPONENT WAS RETAINED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 19773014 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPECTED TO BE INFECTED, DR REQUESTED TO DO A POLY EXCHANGE WITH IRRIGATION AND DEBRIDEMENT (I&D). IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024; DOR- (B)(6) 2024; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19097905 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO DELAY.

  Patient problems: Pain

  MAUDE report 18806425 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PREVIOUS TOTAL KNEE REVISION SURGERY BY THE SURGEON AT THE SAME FACILITY IN (B)(6) 2023. PATIENT CAME IN FOR AN IRRIGATION AND DEBRIDEMENT (I&D) AND POLY EXCHANGE FOR A SUSPECTED INFECTION. DOI: UNKNOWN. DOR: (B)(6), 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18629050 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO REPORTS OF SURGICAL DELAYS.

  Patient problems: Adhesion(s); Discomfort; Joint Contracture; Loss of Range of Motion

  MAUDE report 17540192 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND UNDERWENT REMOVAL OF THE POLY FOR WASHOUT DUE TO INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17199049 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STILL DRAINING AND SURGEON ELECTED TO WASH OUT AND CHANGE COMPONENTS THAT HE WAS ABLE TO. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 16417812 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS PERSISTENT BLOODY EFFUSION SINCE LAST SURGERY. SURGEON CHOOSES SURGICAL EXPLORATION AND I&D AS TREATMENT. LITTLE IS FOUND AND FROZEN SECTIONS ARE NEGATIVE. PATIENT DOES "OOZE" BUT NOT BLEEDERS FOUND. SURGEON NOTES MOTION LESS THAN HE WOULD PREFER AND CHOOSES TO REDUCE THE FEMORAL LENGTH BY CHANGING SEGMENTS. NO PATIENT HARM WAS NOTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Swelling/ Edema

  MAUDE report 16231979 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PRIOR LEFT TOTAL KNEE REVISION. PATIENT WAS BROUGHT TO OR FOR SUSPECTED INFECTION. PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT OF THE LEFT KNEE WITH A POLYETHYLENE REPLACEMENT. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16204733 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DVT IN HER ARM FROM A PIC LINE POST OPERATIVELY. SHE WAS ANTICOAGULATED AND CAUSED A SWELLING IN HER KNEE. INCISION UNFORTUNATELY CAME OPEN DUE TO INCREASED SWELLING AND AN I&D WAS PERFORMED. SURGEON CHOSE TO EXCHANGE MODULAR COMPONENTS AT THE TIME OF SURGERY. NO PATIENT HARM OCCURRED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Wound Dehiscence

  MAUDE report 15804082 ↗
• MalfunctionOct 7, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  ADDITIONAL INFORMATION RECEIVED. THE AFFECTED SIDE OF THE PATIENT WAS THE LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15561779 ↗