LPS 1987-06-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10603295078494), received between Aug 30, 2017 and Jul 27, 2026 — classified as 50 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K040281, K071417); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• 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 50025122 ↗
• 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 24679570 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANT STIFFNESS WITH ESSENTIALLY NO MOTION POST REVISION TKA FOR STIFFNESS. SURGEON IS NOT SURE WHY PATIENT IS SO STIFF AS NO INFECTION IS PRESENT BASED ON LABS AND FROZEN SECTION. ALL COMPONENTS WERE REMOVED. FEMORAL SLEEVE WAS NOT INGROWN ALMOST 5 MONTHS POST OP. THERE WAS NO RADIOGRAPHIC INDICATION THAT COMPONENT WOULD BE LOOSE. TIBIAL COMPONENTS WERE SUBSEQUENTLY REMOVED TO LOWER THE JOINT LINE AS THE PATELLA WAS IMPINGING THE INSERT AFTER REVISING THE FEMUR. THIS IS LIKELY A RESULT OF SHORTENING OF THE PATELLAR TENDON DUE TO LACK OF MOTION. TIBIAL SLEEVE WAS ONLY PARTIALLY INGROWN. NO DELAY NOR PATIENT HARM WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 23709392 ↗
• 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 22872636 ↗
• 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 22214717 ↗
• 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: Swelling/ Edema; Unspecified Infection

  MAUDE report 22160373 ↗
• 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 OPERATING ROOM (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 PROC

  Patient problems: Extraskeletal ossification; Unspecified Infection

  MAUDE report 22159223 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 22021550 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POOR PATELLAR TRACKING AND WAS SCHEDULED FOR SURGERY TO ADDRESS. AFTER EXPOSURE, SURGEON NOTED THE FEMORAL COMPONENT APPEARED TO BE INTERNALLY ROTATED. WHILE EXTRACTING THE FEMORAL COMPONENT HE NOTICED THAT THE FEMORAL SLEEVE ALSO MOVED INDICATING THAT IT HAD NOT YET INGROWN. THIS LED THE SURGEON TO BELIEVE THAT THE PATIENT COULD STILL BE INFECTED AS HE WAS TREATED AT THE PREVIOUS SURGERY WITH A ONE STAGE REVISION FOR INFECTION. FROZEN SECTION WAS SENT TO PATHOLOGY AND SHOWED 5 WHITE CELLS/ HIGH POWERED FIELD. THIS RESULT WAS MORE INDICATIVE OF A LOOSE COMPONENT THAN INFECTION BUT SURGEON FELT COMPELLED TO PROCEED AS IF INFECTED AND ALSO SENT CULTURES. FEMORAL COMPONENTS WERE REMOVED AND A THOROUGH DEBRIDEMENT AND IRRIGATION WAS PERFORMED. FEMUR WAS THEN PREPARED FOR NEW COMPONENTS AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY WAS ENCOUNTERED AND NO PATIENT HARM NOTED. PATELLAR TRACKING AND MOTION WERE FOUND TO BE IMPROVED WITH NEW COMPONENTS IN PLACE. THERE WAS LOOSENING REPORTED AT NON-CEMENTED INTERFACE AT FEMORAL SLEEVE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 21952687 ↗
• 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: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 21944660 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTS WERE REMOVED DUE TO INFECTION. A SPACER WAS PLACED UTILIZING LPS COMPONENTS IN A DUAL SET UP FASHION IN CONJUNCTION WITH A THOROUGH I&D WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY NOR PATIENT HARM TOOK PLACE. NO ALLEGATION WAS MADE AGAINST ANY COMPONENTS AT THIS TIME, AS ALL WERE WELL FIXED AND WELL FUNCTIONING. FEMORAL SIDE HAD BEEN REVISED ON (B)(6) 2023 AND AGAIN ON (B)(6) 2024. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20426460 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN TO DRAIN AGAIN POST ANTIBIOTIC SPACER FASHIONED WITH LPS COMPONENTS. ALL COMPONENTS WERE REMOVED. DURING DISSECTION AND REMOVAL, A VASCULAR INJURY OCCURRED. THE VASCULAR TEAM CAME IN TO REPAIR THE VESSELS. A NEW SPACER UTILIZING LPS COMPONENTS WAS PLACED AFTER A THOROUGH DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS A DELAY IN THE PROCEDURE AND HARM DID OCCUR BUT THERE WAS NO MENTION OF ALLEGATION AGAINST ANY DEPUY COMPONENTS CAUSING SAID INJURY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Perforation of Vessels

  MAUDE report 20239637 ↗
• 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 19928213 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FOLLOWING IMPLANTS SUBSIDED. RIGHT LPS DISTAL FEMUR, UNIVERSAL FEMORAL SLEEVE, LPS ADAPTER AND UNIVERSAL STEM SUB-SITED LEAVING PATIENTS LEG SHORT ON THAT RIGHT SIDE. ALSO THE ATTUNE REVISION TIBIA, ATTUNE REVISION TIBIAL SLEEVE AND STEM WERE LOOSE. SURGEON EXPLANTED ALL IMPLANTS EXCEPT THE PATELLA. SURGEON REVISED AND REPLACED THE IMPLANTS. THERE WAS LOOSENING OF ALL IMPLANTS AT THE BONE TO CEMENT INTERFACE. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Physical Asymmetry

  MAUDE report 19033295 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2019, DOR- (B)(6) 2023, AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17481078 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON CONVERTED A PROXIMAL FEMUR TO LPS TOTAL FEMUR FOR STABILITY REASONS. THERE WAS NO SURGICAL DELAY AND NO CEMENT INFORMATION AVAILABLE FOR PRIMARY OR CURRENT SURGERY. DOI: (B)(6) 2022. DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16910136 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE INSERTED ON 2 DIFFERENT DATES AS A PARTIAL REVISION WAS PERFORMED ON THE SECOND DATE, (B)(6) 2021. A DER WAS SUBMITTED AT THAT TIME. FIRST 3 ITEMS LISTED WERE LEFT FROM (B)(6) 2020 PROCEDURE, THE REST WERE PLACED IN MAY 21. PATIENT COMPLAINED OF TIBIAL PAIN. XRAYS APPEARED TO HAVE LUCENCIES ON THE TIBIAL SIDE SO A TIBIAL SIDE REVISION WAS PLANNED. INSERT AND FEMORAL COMPONENT WERE REMOVED FOR EXPOSURE, THEN TIBIAL TRAY AND STEM WERE REMOVED, BUT THE TIBIAL SLEEVE WAS FOUND TO BE WELL FIXED. THE SURGEON WANTED TO SHORTEN THE ADAPTER ON THE FEMORAL SLEEVE AND WHEN TRYING TO REMOVE THE ADAPTER THE FEMORAL SLEEVE AND STEM WERE EXTRACTED. AT THIS POINT, A TIBIAL AND FEMORAL REVISION WERE PERFUMED UNEVENTFULLY. THERE WAS NO PATIENT HARM. DOI: (B)(6) 2020. DOR: (B)(6) 2022 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15526007 ↗
• InjurySep 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  KNEE PROSTHESIS WHICH HAD BEEN PLACED ON (B)(6) 2022. ON (B)(6) 2022: SECONDARY PROSTHETIC DISPLACEMENT WITH ROTATIONAL DISORDER -> EXTERNAL HYPER-ROTATION OF THE LOWER LIMB SECONDARY TO A PROSTHETIC ROTATIONAL DISORDER OCCURRING AT THE LPS PROSTHETIC METAPHYSIS/SLEEVE JUNCTION CEMENTED IN THE FEMUR. HYPER EXTERNAL ROTATION OF THE RIGHT LOWER LIMB DURING FLEXION RISK OF MICROMOBILITY OF A METAL-METAL COUPLE. RETURN TO THE OPERATING ROOM. ARTHROTOMY FOR REPLACEMENT OF THE DEFECTIVE PART.

  Patient problems: Insufficient Information

  MAUDE report 15410777 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION PRESENT WITHIN KNEE. CONVERTED TO ABX SPACER. IT IS UNKNOWN IF ANY LOOSENING. THERE IS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14513862 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO A DISLOCATION BECAUSE THE KNEE WAS TO TIGHT IN FLEXION CAUSING THE INSERT TO SEPARATE FROM THE TIBIAL COMPONENT. THE DOCTOR DECIDED TO CHANGE THE ADAPTOR FROM A 5 TO A 0 AND ALSO DECIDED TO REPLACE THE FEMUR AND INSERT AS WELL. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 14016559 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION KNEE SURGERY IN (B)(6) 2020. PATIENT APPEARED IN THE EMERGENCY ROOM WITH AN INFECTED TOTAL KNEE. SURGEON REMOVED DISTAL FEMUR AND INSERT AND PERFORMED AN IRRIGATION AND DEBRIDEMENT AND REPLACED THE PARTS REMOVED WITH THE SAME SIZES BUT NEW IMPLANTS. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14013368 ↗
• 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 13827206 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI (B)(6) 2014: THE INFECTION WAS CLEARED AND AN LPS DISTAL FEMUR, SEGMENT COMPONENT, SLEEVE ADAPTOR, FEMORAL SLEEVE, LPS TIBIAL HINGE INSERT, UNIVERSAL STEM, MBT TRAY, MBT SLEEVE, AND UNIVERSAL STEM (SEE ADDITIONAL INFORMATION PROVIDED WITH PART/LOT) WAS IMPLANTED. A FREE LATISSIMUS DORSI FLAP WITH VEIN GRAFTING TO CORRECT A LEFT KNEE SKIN DEFECT PRESENT BEFORE THE REVISION WAS ALSO PERFORMED. POSTOPERATIVELY, THE DEVELOPED ACUTE RENAL FAILURE REQUIRING INCREASING IV FLUIDS. THIS WAS CAPTURED IN (B)(4). (B)(6) 2014: THE LATISSIMUS DORSI FLAP IS POSITIVE FOR PSEUDOMONAS AND STENOTROPHOMONAS MALTOPHILIA REQUIRING IV ANTIBIOTICS AND A WOUND VAC DRESSING TO ADDRESS THE DRAINAGE. THE INFECTION IS CLEARED THOUGH THE PATIENT IS TOLD TO REMAIN ON CHRONIC ANTIBIOTICS. THIS WAS CAPTURED IN (B)(4). (B)(6) 2014: THE EXTENSOR MECHANISM HAS ¿SLID PROXIMALLY¿ CAUSING BONE GRAFT TO COME LOOSE AND PATELLA TO RIDE HIGH PER RADIOGRAPHS IN REFERENCE TO HIS ALLOGRAFT RECONSTRUCTION WITH RESIDUAL ROM AND STRENGTH DEFICITS. NO SURGICAL INTERVENTION IS TO BE DONE. HE IS TO CONTINUE PHYSICAL THERAPY ONLY. THIS WAS CAPTURED IN (B)(4). EARLY (B)(6) 2014: THE PATIENT SUSTAINS A FALL DUE TO A SENSE OF INSTAB

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13584015 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI (B)(6) 2014: THE INFECTION WAS CLEARED AND AN LPS DISTAL FEMUR, SEGMENT COMPONENT, SLEEVE ADAPTOR, FEMORAL SLEEVE, LPS TIBIAL HINGE INSERT, UNIVERSAL STEM, MBT TRAY, MBT SLEEVE, AND UNIVERSAL STEM (SEE ADDITIONAL INFORMATION PROVIDED WITH PART/LOT) WAS IMPLANTED. A FREE LATISSIMUS DORSI FLAP WITH VEIN GRAFTING TO CORRECT A LEFT KNEE SKIN DEFECT PRESENT BEFORE THE REVISION WAS ALSO PERFORMED. POSTOPERATIVELY, THE DEVELOPED ACUTE RENAL FAILURE REQUIRING INCREASING IV FLUIDS. THIS WAS CAPTURED IN (B)(4). (B)(6) 2014: THE LATISSIMUS DORSI FLAP IS POSITIVE FOR PSEUDOMONAS AND STENOTROPHOMONAS MALTOPHILIA REQUIRING IV ANTIBIOTICS AND A WOUND VAC DRESSING TO ADDRESS THE DRAINAGE. THE INFECTION IS CLEARED THOUGH THE PATIENT IS TOLD TO REMAIN ON CHRONIC ANTIBIOTICS. DOI: (B)(6) 2014, DOE: (B)(6) 2014 AFFECTED KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13535249 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI (B)(6) 2014: THE INFECTION WAS CLEARED AND AN LPS DISTAL FEMUR, SEGMENT COMPONENT, SLEEVE ADAPTOR, FEMORAL SLEEVE, LPS TIBIAL HINGE INSERT, UNIVERSAL STEM, MBT TRAY, MBT SLEEVE, AND UNIVERSAL STEM (SEE ADDITIONAL INFORMATION PROVIDED WITH PART/LOT) WAS IMPLANTED. A FREE LATISSIMUS DORSI FLAP WITH VEIN GRAFTING TO CORRECT A LEFT KNEE SKIN DEFECT PRESENT BEFORE THE REVISION WAS ALSO PERFORMED. POSTOPERATIVELY, THE DEVELOPED ACUTE RENAL FAILURE REQUIRING INCREASING IV FLUIDS. DOE: (B)(6) 2014.

  Patient problems: Renal Failure

  MAUDE report 13535065 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040281, K071417. One submission often covers many models, so check the product and lot details in each record.

• Z-0829-2013 · Jan 4, 2013 · Terminated
  LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct sever
• Z-0828-2013 · Jan 4, 2013 · Terminated
  LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct sever
• Z-0830-2013 · Jan 4, 2013 · Terminated
  LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct sever
• Z-0831-2013 · Jan 4, 2013 · Terminated
  LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct sever