LCS COMPLETE AOXRecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 0
We found 10 models of LCS COMPLETE AOX by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2017 and Oct 15, 2025 — classified as 20 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 LCS COMPLETE AOX problems
Device problems
- Adverse Event Without Identified Device or Use Problem12
- Insufficient Device Problem Information4
- Device Dislodged or Dislocated2
- Appropriate Device Problem Term/Code Not Available1
- Loose or Intermittent Connection1
- Naturally Worn1
Patient problems
- No Code Available10
- Pain6
- Unspecified Infection5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Injury2
- Joint Laxity2
- Abscess1
- Edema1
LCS COMPLETE AOX models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LCS COMPLETE AOX 1294-18-610Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing5 reports
- LCS COMPLETE AOX 1294-18-512Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing3 reports
- LCS COMPLETE AOX 1294-18-410Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing2 reports
- LCS COMPLETE AOX 1294-18-412Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing2 reports
- LCS COMPLETE AOX 1294-18-510Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing2 reports
- LCS COMPLETE AOX 1294-18-515Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing2 reports
- LCS COMPLETE AOX 1294-17-310Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 report
- LCS COMPLETE AOX 1294-17-510Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 report
- LCS COMPLETE AOX 1294-18-415Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 report
- LCS COMPLETE AOX 1294-18-517Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 report
Recent LCS COMPLETE AOX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT KNEE BECAME UNSTABLE. SURGEON ATTEMPTED TO SWAP THE POLY FOR A LARGER SIZE BUT HAD TO REMOVE/REPLACE THE FEMUR AND POLY. DOI: (B)(6) 2017, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.
Patient problems: Joint Laxity
MAUDE report 23286474 ↗InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT PRIMARY LEFT IMPLANTS ON (B)(6) 2020. SHE HAD AN I&D AND REPLACEMENT OF POLY ON (B)(6) AND (B)(6) 2020 ((B)(4)). THIS PATIENT IS VERY SICK WITH MULTIPLE COMORBIDITIES. SHE HAD AN ABSCESS ON THE LEFT KNEE SURGICAL SITE. THERE WAS NOTICEABLE ASEPTIC LOOSENING OF THE FEMORAL AND PATELLA COMPONENTS. ALL IMPLANTS WERE REMOVED WITH NO PLAN TO REIMPLANT. SURGEON PERFORMED AN END-STAGE ARTHRODESIS. HER RIGHT KNEE WAS PERFORMED YEARS AGO AND SEEMS TO BE UNAFFECTED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.
Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12480936 ↗InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS THE NEED FOR A THICK POLY FOR STABILITY. DOI: (B)(6) 2018, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT.
Patient problems: Joint Laxity
MAUDE report 12460152 ↗InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED TOTAL KNEE, SURGEON ELECTED TO REMOVE ALL IMPLANTS AND PERFORM AN ANTIBIOTIC SPACER. NO DELAY TO SURGERY REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2021. LEFT KNEE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11544506 ↗InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD AN INFECTED WOUND SITE AFTER A TKA ON (B)(6) 2020 .THE INFECTION WAS PAST THE DERMAL LAYER AND SURGEON WAS CONCERNED IT MAY HAVE SPREAD TO THE JOINT SPACE. SURGEON REMOVED POLY AND PERFORMED AN I & D AND PLACED IN A NEW POLY.
Patient problems: Insufficient Information
MAUDE report 10958657 ↗InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SURGEON PLANNED FOR A RIGHT HIP REVISION OF A (B)(6) YRS OLD FEMALE. PATIENT HAD A P.F.C. CEMENTED HIP, A PFC CUP, PFC LINER, 28+0 HEAD AND 2 SCREWS. ALL REMOVED AND REPLACED WITH A REVISION. HAD WE BEEN ABLE TO SOURCE A REPLACEMENT PFC ACETABULAR LINER AND ALL 28 AND 32 PFC HEAD OPTIONS, THIS SURGERY WOULD HAVE TAKEN 30 MINUTES INSTEAD OF 4 HOURS. THE SURGEON WAS AWARE OF THE LIMITED AVAILABILITY AND HIS PLAN A IF EVERYTHING WENT WELL WAS JUST TO CHANGE THE PFC HEAD WITH A 32+0 OPTION (ONLY ONE AVAILABLE) AND A MULTI HOLE GRIPTION CUP WITH A 32 ALTRX LINER. HOWEVER, PATIENT WAS MORE UNSTABLE THAN EXPECTED SO THE SURGEON REMOVED THE STEM&CEMENT, REMOVED CUP, LINER, SCREWS AND HEAD. REPLACED WITH A STRYKER DM CUP AND A LONG CEMENTED EXETER.
Patient problems: No Code Available
MAUDE report 10756517 ↗InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT PRIMARY SURGERY WAS OF THE LEFT KNEE ON (B)(6) 2020. PATIENT DEVELOPED A HEMATOMA. SO SURGEON PERFORMED AN I&D ON (B)(6) 2020 AND EXCHANGED THE POLY LINER. ATTACHED IS THE DGR FROM ORIGINAL SURGERY WITH THE REMAINING COMPONENTS. I HAVE NO FURTHER INFORMATION TO ADD. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION?: NO, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING?: YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL?: YES, FACILITY NAME OF ORIGINAL IMPLANT: DCH, WAS DEVICE EXPLANTED?: TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: HEMATOMA AND NEED TO PERFORM A COMPLETE IRRIGATION, DID PATIENT REQUIRE REVISION SURGERY?: TRUE, IF YES, DATE OF REVISION SURGERY: 7/20/2020, REASON FOR REVISION SURGERY: EVACUATION OF A HEMATOMA, PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?: HEMATOMA, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE: EVACUATION OF
Patient problems: No Code Available
MAUDE report 10351382 ↗InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEFT TOTAL KNEE DONE AT (B)(6) ON (B)(6) 2020. PATIENT DEVELOPED AN INFECTION SO REMOVED POLY AND PERFORMED AN I&D. THE PATIENT EXHIBITED SOME SYMPTOMS OF COVID19, SUCH AS A COUGH AND SLIGHT FEVER, HOWEVER CHEST XRAY SEEMED CLEAR. ALL COVID19 PRECAUTIONS WERE ADHERED TO DURING REVISION SURGERY.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9940073 ↗InjuryDec 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS PAIN, SWELLING AND INFECTION. THE INSERT AND PATELLA POLY WERE CHANGED DURING A WASHOUT FOR INFECTION. DOI: (B)(6) 2014. DOR: (B)(6) 2019, LEFT KNEE.
Patient problems: Edema; No Code Available; Pain; Unspecified Infection
MAUDE report 9526012 ↗InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.
Patient problems: No Code Available; Pain
MAUDE report 9476026 ↗InjurySep 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT HAS HAD RECENT KNEE PAIN POST SURGERY ON (B)(6) 2019. THE POLY HAD COMPLETELY SPUN POSTERIORLY. PATIENT DENIES ANY FALL OR OTHER TRAUMA. SURGEON REMOVED POLY AND REPLACED WITH A THICKER ONE.
Patient problems: Joint Dislocation; No Code Available; Pain
MAUDE report 8969685 ↗InjuryAug 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT NEEDED A LARGE INSERT. DOI: UNKNOWN. DOR: (B)(6) 2019. LEFT KNEE.
Patient problems: No Code Available
MAUDE report 8925296 ↗InjuryJun 12, 2019Naturally Worn; Naturally Worn
THERE WAS A LOOSE TIBIA WITH A LCS RPS PRIMARY KNEE. THE MEDIAL PROX. TIBIAL BONE GAVE WAY UNDER THE TRAY CAUSING IT TO COLLAPSE. THE FEMUR LOOKED FINE BUT WAS REMOVED DUE TO LIGAMENT INSTABILITY. THE POLY SHOWED SOME PITTING BUT IT HAD BEEN IN ABOUT 10 YEARS. THE FEMUR HAD SOME LYSIS BEHIND THE FEMUR.
Patient problems: Injury; No Code Available; Osteolysis
MAUDE report 8692804 ↗InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFECTED KNEE. REMOVAL OF ALL IMPLANTS. NO EXTRA SURGICAL TIME NEEDED.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8550886 ↗InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT UNDERWENT ORTHOPEDIC SURGERY ON OR ABOUT (B)(6), 2017 AND (B)(6), 2017, AND WAS IMPLANTED WITH DEPUY SYNTHES DEVICES WHICH SUBSEQUENTLY MALFUNCTIONED OR FAILED, CAUSING PLAINTIFF INJURIES, DEBILITATION AND NECESSITATING FURTHER MEDICAL INTERVENTIONS.
Patient problems: Injury; No Code Available; Pain
MAUDE report 8448015 ↗
Other Depuy Orthopaedics, Inc. products
- PINNACLE ALTRX98 models · 5,631 reports
- BIOLOX DELTA40 models · 4,995 reports · 1 recall
- PINNACLE182 models · 4,587 reports
- QUICKSET7 models · 3,790 reports
- PINNACLE POROCOAT38 models · 2,112 reports
- SUMMIT POROCOAT20 models · 1,646 reports
- PINNACLE GRIPTION57 models · 1,608 reports
- DURALOC93 models · 1,262 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page