LPS 1987-15-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10603295078722), received between Jul 21, 2017 and Apr 13, 2026 — classified as 80 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND OPENED INCISION. DOI: (B)(6) 2026, DOR: (B)(6) 2027, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 24861647 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D POLY SWAP. DOI: UNKNOWN. DOR: (B)(6), 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22846107 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUED TO DRAIN FROM KNEE WOUND. SURGEON ELECTED TO REMOVE KNEE PROSTHESIS AND FUSE THE KNEE. THIS COMPLAINT(B)(4). . DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22329018 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY OPERATED ON FOR AN INFECTED NON-UNION OF FUSION. SINCE CULTURES WERE NEGATIVE, SURGEON CHOSE TO REIMPLANT THE PATIENT. CONTINUED DRAINAGE SUGGESTS INFECTION. SINCE THE PATIENT CONTINUES TO DRAIN DESPITE NEGATIVE CULTURES, THE SURGEON CHOSE TO REMOVE ALL COMPONENTS AND CONVERT TO A STATIC SPACER UTILIZING LPS COMPONENTS, PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND HIGH DOSE ANTIBIOTIC CEMENT TO COAT THE COMPONENTS. ALL COMPONENTS WERE WELL FIXED BUT LACK OF BONY INGROWTH ALSO SUGGESTS PERSISTENT INFECTION. AN I&D WAS PERFORMED ON (B)(6) 2025, WHERE THE POLY AND PIN WERE REPLACED. DEPUY 2 WITH GENTAMICIN WAS LIKELY UTILIZED, AS THAT IS THE SURGEON'S NORM. NO DELAY OCCURRED AND NO PATIENT HARM WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22214718 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2024. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19840898 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: -NO SURGICAL DELAY. NO PATELLA IMPLANT USED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19154674 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED LEFT KNEE. REMOVE ATTUNE LPS XXSMALL 12MM INSERT AND LPS XXSMALL HINGE PIN AND REPLACED WITH NEW OF THE SAME SIZE. WASH OUT & ID. THERE WAS NO LOT NUMBER ON THE HINGE PIN THAT WAS TAKEN OUT. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. (B)(6). AFFECTED SIDE: RIGHT

  Patient problems: Unspecified Infection

  MAUDE report 18277539 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED KNEE, POLY EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18172948 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION FROM A PREVIOUS DISTAL FEMUR REPLACEMENT. THE DOCTOR WASHED OUT THE KNEE AND REPLACED THE POLY AND HINGE PIN. THIS WAS THE SECOND POLY SWAP FOR THIS KNEE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6), 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17957613 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LPS HINGE PIN AND POLY SWAP OUT WITH AN I&D. SALES REPRESENTATIVE NOT PRESENT FOR SUSPECTED INFECTION. THERE WAS NO WAY TO CONFIRM IF INFECTION IS PRESENT. SALES REPRESENTATIVE NOT AT CASE, LOT NUMBERS WERE RECORDED ON EXPLANT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 16752909 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. NO OTHER INFORMATION AVAILABLE. ORIGINAL DATE OF IMPLANTATION WAS UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16140740 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEVERE RHEUMATOID ARTHRITIS AND DEVELOPED A SIGNIFICANT FLEXION CONTRACTURE. THE SURGEON'S BELIEF WAS THE EASIEST WAY TO ADDRESS WAS TO SHORTEN THE FEMORAL SIDE. THE FEMORAL COMPONENT WAS REMOVED, THE FEMUR RESECTED UNTIL THE KNEE WOULD STRAIGHTEN AND NEW COMPONENTS WERE PLACED WITH NO COMPLICATIONS OR HARM. NO SURGICAL DELAY. DOI: (B)(6) 2014. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 14955957 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14594098 ↗
• InjuryMay 31, 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 14549466 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO OPEN INFECTED WOUND OF A RIGHT DISTAL FEMORAL REPLACEMENT. PATIENT FELL ON RIGHT KNEE AND FRACTURED PATELLA. THERE IS NO REPORTED LOOSENING. NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 14490221 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT FILLED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT(CER)FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS IMPLANTED WITH DEPUY SYN. (46) HIP COHORT -INVOLVING PROXIMAL FEMORAL BODY IMPLANT . (72) KNEE COHORT-INVOLVING DISTAL FEMUR IMPLANT. (13) TOTAL -INVOLVING BOTH PROXIMAL AND DISTAL IMPLANTS. (72) NONE-NOT REQUIRING THE PROXIMAL OR DISTAL IMPLANT. COMPLICATIONS SUSTAINED WITHIN 5 YEAR REVIEW : 53 PATIENTS SUSTAINED A SUBSEQUENT SURGERY AFTER THE PRIMARY IMPLANTATION OF LPS PRODUCTS 76 PATIENTS HAD AN INFECTION AFTER THE PRIMARY IMPLANTATION OF LPS PRODUCTS 75 PATIENTS HAD A MECHANICAL COMPLICATION AFTER THE PRIMARY IMPLANTATION OF LPS PRODUCTS

  Patient problems: Unspecified Infection

  MAUDE report 14083789 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO (HO)HETEROTOPIC OSSIFICATION AND BECAME QUITE STIFF. FROZEN SECTION WAS NEGATIVE AND NO LABS INDICATED INFECTION. HO WAS REMOVED BUT PATIENT WAS STILL NOT A MOBILE AS THE SURGEON WOULD PREFER. FEMORAL SIDE WAS SHORTENED BY CHANGING FEMORAL COMPONENTS AND USING A 0 ADAPTER. THE NEW PIN, WHICH COMES WITH EVERY NEW DISTAL FEMUR WAS USED. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Extraskeletal ossification; Muscular Rigidity

  MAUDE report 13827225 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13560831 ↗
• MalfunctionFeb 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  HINGE PIN DOESN'T CONNECT TO THE TRIAL. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506781 ↗
• InjuryJan 17, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISLOCATING HINGE. ONLY POLY AND PIN WAS REVISED. DOI: UNKNOWN. DOR: (B)(6) 2021. UNKNOWN KNEE SIDE.

  Patient problems: Insufficient Information

  MAUDE report 13265903 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT INSERT WAS INSERTED ON (B)(6) 2021 AND FEMUR INSERTED ON (B)(6) 2021. SURGEON DECIDED TO DO AN I&D AND EXPLORATION OF KNEE DUE TO UNEXPLAINED PAIN AND POSITION OF PATIENT, EVEN HAD SUSPICION SEPSIS OF HIP DUE TO PATIENT PRESENTATION, HYPER FLEXED AND EXTERNALLY ROTATED. HIP ASPIRATION WAS NEGATIVE. FEMORAL COMPONENT WAS REMOVED AS IT APPEARED THAT EXTERNAL ROTATION WAS INCREASED RELATIVE TO WHERE IT HAD BEEN PLACED AT THE PREVIOUS PROCEDURE. AN INSERT 2MM THINNER WAS USED AS FULL EXTENSION WAS NOT OBTAINED PRIOR TO SURGERY. NO INDICATION OF INFECTION WERE PRESENT IN THE KNEE, HOWEVER SPECIMENS WERE SENT FOR CONFIRMATION. DOI: (B)(6) 2021 (TIBIAL INSERT); (B)(6) 2021 (FEMORAL); DOR: (B)(6) 2021; RIGHT KNEE. THIS COMPLAINT IS RELATED TO (B)(4) WHICH REPORTS THE FIRST REVISION.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13250880 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13169179 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED SECONDARY TO PAIN. DOI: (B)(6) 2020. DOI: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13023460 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY EXCHANGED AND WASHED OUT WAS DONE BY THE SURGEON. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12893330 ↗
• MalfunctionOct 20, 2021Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  THE PARCEL WAS BROKEN IN THE FOIL. NO ISSUES WITH THE OUTER BOX..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12668995 ↗