LPSRecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 96
- Deaths reported
- 0
- Injuries reported
- 81
- Recalls
- 0
We found 4 models of LPS by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 96 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2017 and Jul 27, 2026 — classified as 81 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Break” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LPS problems
Device problems
- Adverse Event Without Identified Device or Use Problem68
- Break9
- Device Dislodged or Dislocated4
- Difficult to Insert2
- Insufficient Device Problem Information2
- Naturally Worn2
- Device-Device Incompatibility1
- Disassembly1
Patient problems
- Unspecified Infection36
- No Code Available23
- Pain15
- No Clinical Signs, Symptoms or Conditions8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Swelling/ Edema6
- Joint Laxity5
- No Consequences Or Impact To Patient5
LPS models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LPS 1987-06-005PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER51 reports
- LPS 1987-06-010PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER17 reports
- LPS 1987-06-000PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- LPS 2987-71-000EXTRACTOR12 reports
Recent LPS adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER IN (B)(6) 2025 WITH BILATERAL INFECTED KNEES FROM AN ACUTE INFECTION IN THE PATIENTS BLOOD. IT AFFECTED BOTH THE KNEES WHICH HAD REV IMPLANTS IN AND BOTH THE SHOULDERS WHICH HAD NO IMPLANTS. PATIENT WAS WASHED OUT AND IMPLANT EXCHANGES TOOK PLACE ON 2 SEPARATE OCCASIONS AT A DIFFERENT FACILITY. PATIENT CAME INTO CLINIC FOR FOLLOW UP ON (B)(6) 2025 AND BOTH KNEES APPEARED TO STILL BE INFECTED. CULTURES SHOWED A SENSITIVE STREP. SURGEON ADMITTED THE PATIENT AND BILATERAL KNEE REVISIONS WERE PERFORMED IN A ONE STAGE FASHION TO INCLUDE THOROUGH IRRIGATION AND DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THIS WAS FROM AN ORGANISM IN PATIENT BLOOD THAT AFFECTED MULTIPLE JOINTS IN PATIENT'S BODY. DATE OF IMPLANTATIONS: RIGHT REVISION KNEE WAS (B)(6) 2016. NO INFORMATION WAS AVAILABLE WITH REGARD TO PRODUCTS EXPLANTED ON (B)(6) 2016. LEFT REVISION KNEE WAS (B)(6) 2023. NO INFORMATION AVAILABLE WITH REGARD TO PRODUCTS EXPLANTED ON (B)(6) 2023. ON (B)(6) 2025, AN I&D AND INSERT EXCHANGE TOOK PLACE FOR THE LEFT KNEE FOR HEMATOMAS, AND P
Patient problems: Unspecified Infection
MAUDE report 21890069 ↗MalfunctionFeb 25, 2025Break; Break
IT WAS REPORTED THAT THE PARTS BROKE INTO TWO WHERE THE CONNECT TRYING TO DISASSEMBLE A LPS COMPONENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21462655 ↗MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT DURING SURGERY, THE SLEEVE/STEM SEPARATOR WAS TOO WORN. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. A SECOND SET WAS OPENED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20543233 ↗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 ↗
Other Depuy Orthopaedics, Inc. products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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