LPS 1987-14-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10603295078715), received between Oct 16, 2017 and Sep 16, 2026 — classified as 86 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 87 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient presents with well fixed and positioned implants post full patellar allograft placement due to quadriceps rupture after revision TKA. Graft is incorporated and patella is in an appropriate position, however the proximal portion of the allograft has become lax. A longer segment is utilized to increase tension and patellar tracking is quite good. A shortening of the proximal tissues is performed and reinforced. A long leg cast is placed to protect the repair post operatively. No allegation is made against the components. No delay nor patient harm is noted. When removing the segment to lengthen the construct, the adapter was removed from the sleeve. There is no record of this device in optimize so not lot information is available.DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected Side: Right.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 50788543 ↗
• InjuryMay 18, 2026Migration

  IT WAS REPORTED THAT PATIENT PRESENTED IN THE ER WITH POOR FUNCTION AND PAIN. FEMORAL COMPONENT APPEARED TO HAVE ROTATED ROUGHLY 90 DEGREES INTERNALLY. THE STEM, SLEEVE AND LPS ADAPTER WERE PLACED INITIALLY AND LEFT IN PLACE WHEN CONVERTED FROM A SPACER TO A REV TKA USING AN IPS DISTAL FEMUR ON (B)(6) 2026. THERE APPEARED TO BE DAMAGE ON THE TAPER OF THE ADAPTER AND UNFORTUNATELY IT COULD NOT BE REMOVED. THE STEM, SLEEVE AND ADAPTER WERE ALL REMOVED AND NEW COMPONENTS WERE PLACED WITH NO DELAY NOR PATIENT HARM. DOIL: ON (B)(6) 2025, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 25205204 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS ADMITTED TO AN OUTSIDE FACILITY POST REV TKA FOR EXCESSIVE BLEEDING THROUGH THE DRESSING AND THE PATIENT WAS TRANSFERRED. PATIENT WAS SCHEDULED FOR AN I&D AND COMPONENT EXCHANGE. ALL COMPONENTS WERE WELL FIXED AND MODULAR WERE EXCHANGED DUE TO RISK OF INFECTION. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT AND NO DELAY NOR PATIENT HARM WAS NOTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25128606 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS NOT HAD A QUADRICEPS MECHANISM POST REVISION TKA ON THE ABOVE LISTED DATE. SURGEON PLACED AN ALLOGRAFT PATELLAR TENDON AND CHOSE TO EXCHANGE COMPONENTS DUE TO DURATION IN VIVO. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT HOWEVER WEAR WAS NOTED ON THE INSERT THAT WAS BELIEVED TO BE ASSOCIATED WITH LACK OF A QUADRICEPS MECHANISM. NO DELAY NOR PATIENT HARM WAS NOTED. SURGEON DID NOT EXCHANGE THE DISTAL FEMORAL COMPONENT DUE TO LACK OF AVAILABILITY. THIS IS NOT CONSISTENT WITH NORMAL REVISION PROTOCOL. DOI: (B)(6) 2018. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24979605 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH POSSIBLE INFECTION; SURGEON ELECTED WASH OUT AND CHANGE OF MODULAR COMPONENTS. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24873291 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HEMATOMA POST REVISION TKA. SURGEON PERFORMED AN EVACUATION OF HEMATOMA WITH A THOROUGH I&D AND COMPONENT EXCHANGE. ALL COMPONENTS WERE WELL FUNCTIONING SO NO ALLEGATION WAS MADE AGAINST ANY COMPONENT, HOWEVER CHOSE TO EXCHANGE MODULAR COMPONENTS AS THE RISK FOR INFECTION IS ELEVATED IN THIS CIRCUMSTANCE. CABLE WAS ALSO REMOVED AS IT COULD HARBOR BACTERIA IF INFECTION IS FOUND TO BE PRESENT ON CULTURES. CULTURES WERE TAKEN AS A PRECAUTION AND RESORBABLE ANTIBIOTIC BEADS WERE PLACED. NO DELAY OR PATIENT HARM WAS NOTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 24730671 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS WITH SOME LAXITY POST REVISION TKA ON THE ABOVE LISTED DATE. THE SURGEON DID NOTE SOME PATELLAR MALTRACKING VIA X-RAY. THE SURGEON CHOSE TO EXCHANGE COMPONENTS TO ADDRESS LAXITY AND INCREASE EXTERNAL ROTATION OF THE FEMORAL COMPONENT. NO ALLEGATION WAS MADE AGAINST ANY COMPONENTS. THERE WAS NO DELAY NOR PATIENT HARM WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24672935 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN LPS DISTAL FEMORAL REPLACEMENT REVISION TKA PLACED ON (B)(6) 2025. HE PRESENTED WITH A DRAINING KNEE AND WAS BROUGHT TO THE OR FOR A ONE STAGE REVISION UTILIZING A DUAL SET UP. ALL COMPONENTS WERE FUNCTIONING AS EXPECTED SO NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. CEMENT WAS DEPUY 2 WITH GENT, HOWEVER IS HOSPITAL OWNED SO NO QTY OR LOT INFORMATION IS AVAILABLE. BOTH TIBIAL AND PATELLAR COMPONENTS WERE WELL FIXED VIA CEMENT SO NO ALLEGATION IS MADE AGAINST THE CEMENT. WHILE WELL FIXED, NO INGROWTH WAS FOUND ON EITHER SLEEVE, FURTHER CONFIRMING INFECTION. A THOROUGH IRRIGATION AND DEBRIDEMENT WAS PERFORMED AFTER ALL COMPONENTS WERE REMOVED. NEW COMPONENTS WERE PREPARED FOR. NEW COMPONENTS WERE OPENED ON A "CLEAN" TABLE AND IMPLANTED AFTER NEW DRAPES AND STAFF CHANGING INTO "CLEAN" GOWNS AND GLOVES WAS COMPLETED. ALL NEW COMPONENTS WERE PLACED ALONG WITH RESORBABLE ANTIBIOTIC BEADS AND ANTIBIOTIC CEMENT. NO DELAY NOR PATIENT HARM WAS NOTED.AFFECTED SIDE- RIGHT KNEE

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 24267208 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATUNE PRESSFIT STR STEM14X60MM, ATUN TIB SLV M/L 45MM FULL POR, ATUNE REV RP TIB BASE SZ 4 CEM, ATTUNE REV LPS INSRT XXSM 12MM, LPS DISTAL FEM COMP XXSM RT, ATT REV SLV LPS FEM ADP +5, ATUN FEM SLV M/L 45MM FULL POR, AND ATUN PRESSFIT STR STEM12X110MM WERE INVOLVED IN A REPORTED EVENT. THE PATIENT, WHO HAD PREVIOUSLY RECEIVED A REVISION KNEE POST SPACER FOR INFECTION, PRESENTED WITH WOUND DRAINAGE. ALL IMPLANTED COMPONENTS WERE REMOVED, AND THOROUGH DEBRIDEMENT AND IRRIGATION WERE PERFORMED. A NEW SPACER WAS FASHIONED USING LPS COMPONENTS, RESORBABLE ANTIBIOTIC BEADS, AND HIGH-DOSE ANTIBIOTIC CEMENT. NO DEVICE MALFUNCTION WAS ALLEGED, AND ALL COMPONENTS WERE REPORTED TO BE FUNCTIONING AS EXPECTED. THE TIBIAL COMPONENT WAS WELL FIXED, AND THE EVENT WAS ATTRIBUTED TO INFECTION RATHER THAN DEVICE FAILURE. ALL LISTED PRODUCTS WERE EXPLANTED DURING THE PROCEDURE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 24258392 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A RUPTURED QUADRICEPS TENDON; SURGEON HAD TO CHANGE COMPONENTS TO ACCOMMODATE THE PATELLAR TENDON ALLOGRAFT THAT WAS USED TO REPAIR THE TENDON DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24059020 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE EXTRACTED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23404440 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PROGRESSIVE LUCENT LINES AROUND COMPONENTS AND PAIN, SUGGESTING FAILED FIXATION. IMPLANTS WERE REMOVED UNEVENTFULLY AND REIMPLANTED WITH NEW COMPONENTS. FROZEN SECTION WAS NEGATIVE FOR INFECTION. CEMENT HAD NOT ADHERED TO THE BONE, BUT THE TIBIAL SLEEVE WAS WELL FIXED AND THUS LEFT IN PLACE. THE FEMORAL COMPONENTS HAD BEEN REVISED ON (B)(6) 2024 FOR FAILED INGROWTH AND A CEMENTED STEM WAS PLACED AT THAT TIME. POLY WAS REVISED (B)(6) 2024 WHEN EXCESSIVE SCAR TISSUE WAS REMOVED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23380113 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT NOT LOOSE, JUST NOT INGROWN. NOT THE SAME THING.

  Patient problems: Unspecified Infection

  MAUDE report 22872243 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS INFECTION AND ALL COMPONENTS WERE REMOVED AND A SPACER WAS MADE WITH NEW COMPONENTS. HIGH DOSE ANTIBIOTICS WERE PLACED ON COMPONENTS ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. HICKMAN CATHETERS WERE ALSO PLACED TO PROVIDE ADDITION ANTIBIOTIC TREATMENT POSTOPERATIVELY. NO PATIENT HARM WAS NOTED AND NO DELAY OCCURRED. INITIAL PROCEDURE FEMORAL SIDE COMPONENTS WERE REVISED ON (B)(6) 2024 A I&D WITH FEMUR AND INSERT EXCHANGE WAS PERFORMED ON (B)(6) 2025 AND (B)(4) WAS SUBMITTED. THERE WAS A LOOSENING REPORTED AT STEM ON BONE TO CEMENT INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22373201 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF MOBILITY. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22293708 ↗
• InjuryJun 17, 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 INSTABILITY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22225721 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO SHOW SIGNS OF INFECTION AND WAS BROUGHT TO THE OR FOR BILATERAL KNEE REVISIONS. COMPONENTS WERE REMOVED AND THOROUGH I&DS WERE PERFORMED IN CONJUNCTION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS, AND PLACEMENT OF NEW COMPONENTS. PATIENT DID HAVE BILATERAL I&DS WITH POLY EXCHANGES ON (B)(6) 2025. AS SUCH, THE INSERTS LISTED ON THIS SUBMISSION WERE FROM THAT DATE. THE RIGHT KNEE SHOWED SIGNIFICANT HETEROTOPIC OSSIFICATION AROUND THE FEMORAL SLEEVE, SUGGESTING INFECTION ON XRAY, SO SURGEON TO CHOSE TO FASHION A STATIC SPACER UTILIZING LPS COMPONENTS TO TREAT THIS SIDE. THE LEFT SIDE APPEARED TO BE DOING BETTER, BUT SINCE HOSPITAL ADMISSION EARLIER THIS WEEK ALSO BEGIN TO SWELL. WHEN CHECKING FIXATION OF THE FEMORAL COMPONENT, THE FEMORAL SLEEVE WAS ABLE TO BE REMOVED WITHOUT SIGNS OF BONY INGROWTH. LACK OF INGROWTH APPROXIMATELY SEVEN (7) WEEKS POST IMPLANTATION SUGGESTS THIS TOO WAS INFECTED. TIBIAL COMPONENT AND STEM WERE LEFT IN PLACE ON THE LEFT SIDE SINCE IT WAS WELL FIXED. NO DELAY NOR PATIENT HARM WAS NOTED. WHILE RESULTS ARE NOT YET AVAILABLE, SURGEON DOES BELIEVE INFECTION WAS STILL PRESENT AT THE TIME OF THIS PROCEDURE. THIS INFEC

  Patient problems: Extraskeletal ossification; Unspecified Infection

  MAUDE report 22159235 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INSTABILITY. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22100017 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH SUSPECTED INFECTION POST REVISION TKA. SURGEON PERFORMS A THOROUGH I&D WITH COMPONENT EXCHANGE WITHOUT DELAY OR PATIENT HARM TO INCLUDE PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO ALLEGATION IS MADE AGAINST ANY COMPONENT AS THEY ARE WELL FUNCTIONING. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22044850 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO REMAIN INFECTED. SURGEON ELECTED TO REMOVE SOME COMPONENTS AND FUSE THE KNEE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22027165 ↗
• InjuryMay 14, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE LOSS OF FIXATION TO THE OSTEOTOMY IS WHAT LED TO THE POOR PATELLAR TRACKING. IMPLANTS WERE PERFORMING AS EXPECTED.

  Patient problems: Joint Laxity

  MAUDE report 22021745 ↗
• InjuryMay 13, 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. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE

  Patient problems: Pain

  MAUDE report 22011861 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POST OPERATIVE HEMATOMA AFTER A COMPLEX PRIMARY KNEE REPLACEMENT UTILIZING REVISION COMPONENTS. ALL COMPONENTS WERE REMOVED AND EXCHANGED UNEVENTFULLY WITH NO PATIENT HARM NOR DELAY. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 21944664 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PATELLAR TENDON ALLOGRAFT PLACED IN CONJUNCTION WITH HER KNEE REVISION. THE PATELLA HAD FRACTURED SINCE THAT TIME AND THE TENDON HAD THEN STRETCHED OUT LEAVING THE INFERIOS AND SUPERIOR POLES OF THE ALLOGRAFT PATELLA ROUGHLY AN INCH AND A HALF APART, BUT NEITHER IN AN APPROPRIATE POSITION FOR THE KNEE TO FUNCTION APPROPRIATELY. ALL COMPONENTS WERE WELL FIXED AND FUNCTIONING AS EXPECTED. THE SURGEON CHOSE TO SHORTEN THE FEMORAL SIDE CONSTRUCT SO THAT THE SUPERIOR PORTION OF THE PATELLA WOULD FUNCTION WITHIN THE PATELLAR FEMORAL GROVE. THE REMAINING ALLOGRAFT WAS THEN ADVANCED AND REPAIRED ACCORDINGLY. THERE WAS NO PATELLAR IMPLANT INVOLVED AS ONE WAS NOT PLACED ON THE ALLOGRAFT AS IT SERVES NO PURPOSE. THERE WAS NO ALLEGATION AGAINST ANY COMPONENT. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM WAS NOTED. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 21217503 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED DISTAL FEMUR REPLACEMENT-POLY, BUMPER, AND PIN SWAP. DISTAL FEMUR IMPLANT STAYED, NEW PIN, BUMPER, AND POLY. NO IMPLANT FAILURE. ALL PIECES RETRIEVED. NO DELAY. SAME SIZES BACK IN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21137037 ↗