TRI-LOCK GRIPTION 1012-04-050Recalls & reported problems
Depuy Orthopaedics, Inc. · TRI-LOCK BPS FEMORAL STEM 12/14 TAPER TRI-LOCK BPS W/GRIPTION SIZE 5 STD 105mm · Class 3 · Implant
All models of TRI-LOCK GRIPTION (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Tri-Lock femoral stem is a metal hip replacement used in total hip arthroplasty. Its 44 reports mostly describe pain, loosening of the implant in the bone, metal wear and elevated metal ion levels, and infection, with several patients needing revision surgery to remove or swap parts. 39 reports describe injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295000761), received between Jul 12, 2017 and Feb 12, 2026 — classified as 39 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (8 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem22
- Loss of Osseointegration8
- Migration3
- Biocompatibility2
- Degraded2
- Fracture2
- Inadequacy of Device Shape and/or Size2
- Insufficient Device Problem Information2
Patient problems
- Pain21
- No Code Available16
- Foreign Body Reaction10
- Test Result9
- Inadequate Osseointegration8
- Discomfort7
- Inflammation6
- Ambulation or Postural Difficulties5
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS INFECTED. THE DEVICES WERE EXPLANTED AND A SPACER WAS IMPLANTED. AFFECTED SIDE-RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 24323817 ↗InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2020 MEDICAL RECORDS NOTE THE PATIENT IS EXPERIENCING SOME NUMBNESS AND TINGLING DOWN THE RIGHT LEG, ALONG WITH RIGHT GROIN PAIN AND WEAKNESS ON (B)(6) 2021 MEDICAL RECORDS NOTE PATIENT HAS BEEN HAVING INCREASED WEAKNESS OF THE ILIOPSOAS MUSCLE RIGHT HIP, THE PATIENT IS SCHEDULED FOR AN INJECTION IN THE ILIOPSOASA MUSCLE. ON (B)(6) 2021 THE PATIENT HAD ILIOPSOAS TENDON INJECTION UNDER FLUOROSCOPIC GUIDANCE TO ADDRESS RIGHT HIP PAIN, ILIOPSOAS BURSITIS, TENDONITIS. NOTED THAT THESE EVENTS HAPPENED AFTER THE (B)(6) 2019, POST RIGHT HIP REVISION CAPTURED IN (B)(4).
Patient problems: Fatigue; Inflammation; Muscle/Tendon Damage; Numbness; Pain
MAUDE report 19462077 ↗InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PERIPROSTHETIC FRACTURE OF A TRI-LOCK STEM FOLLOWING A FALL. REQUIRED REVISION SURGERY. STEM AND HEAD WERE REMOVED, CUP WAS RETAINED.
Patient problems: Fall; Limb Fracture
MAUDE report 18228925 ↗InjuryJul 26, 2023Degraded; Degraded
ADDITIONAL INFORMATION WAS RECEIVED: PLAINTIFF WAS IMPLANTED WITH A MOM PINNACLE SYSTEM IN PLAINTIFF'S HIP ON (B)(6) 2009. THE PATIENT SUFFERED HEAVY METAL POISONING, INJURY AND REQUIRING SURGERY TO REMOVE THE DEFECTIVE HIP REPLACEMENTS. PLAINTIFF WAS FORCED TO UNDERGO SURGICAL REMOVAL DUE TO HEAVY METAL POISONING ON (B)(6) 2022. AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE PINNACLE HIP, PLAINTIFF WAS REQUIRED TO UNDERGO SURGICAL REMOVAL OF THE DEFECTIVE SYSTEM, SUFFERED INJURY TO HIS MUSCLE AND TISSUE, SUFFERED ADDITIONAL SCAR TISSUE FORMATION, AND NOW HAS A HIP REPLACEMENT WITH DECREASED LONGEVITY. AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE PINNACLE HIP REPLACEMENT, PLAINTIFF SUFFERED INJURIES, INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN, INJURY CAUSED BY METALLOSIS, METAL WEAR, AND METAL POISONING. PLAINTIFF EXPECTS TO CONTINUE SUFFERING SUCH INJURIES IN THE FUTURE BECAUSE OF THE INJURIES RECEIVED FROM THE PINNACLE. AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE PINNACLE, PLAINTIFF EXPERIENCED EMOTIONAL TRAUMA AND DISTRESS AND IS LIKELY TO EXPERIENCE EMOTIONAL TRAUMA AND DISTRESS IN THE FUTURE.
Patient problems: Adhesion(s); Distress; Foreign Body Reaction; Metal Related Pathology; Pain; Unspecified Tissue Injury
MAUDE report 17396834 ↗InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED TRUNIONOSIS. TRUNION AND INSIDE OF HEAD HAD VISIBLE TRUNIONOSIS. METAL HEAD ON TRILOCK STEM. HEAD AND LINER EXCHANGE WITH TS CERAMIC HEAD. CHROMIUM LEVEL 2.4. COBALT LEVEL 4.6. NO PSEUDOTUMOR PRESENT ACTIVITY LEVEL - YES.
Patient problems: Foreign Body Reaction
MAUDE report 16742225 ↗InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED WITH PERIPROSTHETIC FRACTURE. REVISED TO ZIMMER STEM/HEAD. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SITE: LEFT HIP.
Patient problems: Limb Fracture
MAUDE report 16427868 ↗InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS ADMITTED TO HOSPITAL FOR INFLAMMATION. SURGERY WAS PERFORMED TO REMOVE METAL ON METAL IMPLANTS, LINER AND HEAD ONLY WAS REMOVED. BONE LOST ON PROXIMAL FEMUR.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Unspecified Tissue Injury
MAUDE report 15528139 ↗InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND METALLOSIS RESULTING TO HIP PAIN AND WALKING DIFFICULTY. OPERATIVE NOTE REPORTED THERE WAS A FAIR AMOUNT OF GRAYISH BROWNISH SYNOVIAL FLUID CONSISTENT WITH METALLOSIS, CUP IS SLIGHT VERTICAL POSITION. CLINICAL VISIT REPORTED RIGHT HIP PAIN, DISCOMFORT, LIMITED ADL, ANTALGIC GAIT AND ELEVATED METAL IONS. DOI: (B)(6) 2009; DOR: (B)(6) 2021; RIGHT HIP.
Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Foreign Body Reaction; Loss of Range of Motion; Osteolysis; Pain
MAUDE report 14349282 ↗InjuryApr 11, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem
REVISION COMPLETED DUE TO CONCERNS OF ELEVATED METAL ION POSSIBILITY. PATIENT REVISED TO A CERAMIC HEAD BALL. DOI: (B)(6) 2008. DOR: (B)(6) 2021. RIGHT HIP.
Patient problems: Ambulation or Postural Difficulties; Discomfort; Distress; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Physical Asymmetry; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 14073555 ↗InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENTS FEMORAL HEAD AND LINER WERE PREVIOUSLY REPLACED ON (B)(6) 2021. SURGEON NOTICED SIGNS OF TRUNIONOSIS WHILE CLEANING OUT THE JOINT. PATIENT LATER RETURNED SHOWING SIGNS OF INFECTION. SURGEON REMOVED THE COMPONENTS AND IMPLANTED A PROSTALAC. SURGEON WOULD LIKE THE TRUNNION EXAMINED ON THE STEM WITH A RESPONSE LETTER OF THE FINDINGS. DOI: UNK; DOR: (B)(6) 2022 (LEFT HIP). PLEASE SEE (B)(4) FOR THE FIRST REVISION.
Patient problems: Foreign Body Reaction; Unspecified Infection
MAUDE report 13584614 ↗InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO FEMORAL FRACTURE. NO MORE INFORMATION. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.
Patient problems: Limb Fracture
MAUDE report 13505969 ↗InjurySep 2, 2021Fracture; Fracture
SURGEON REPORTED TO BFARM (NCA): "FRACTURE OF THE HIP STEM AT NECK AREA." THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2017, DOR: (B)(6) 2021, RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 12413981 ↗MalfunctionJun 10, 2021Nonstandard Device; Difficult to Open or Remove Packaging Material; Nonstandard Device; Difficult to Open or Remove Packaging Material
LAYER STRIPPING. IT WAS REPORTED THAT THE PATIENT'S INDICATION WAS OSTEOARTHRITIS, DURING THE SURGERY OF REPLACEMENT OF TOTAL HIP, WHEN OPENED PACKING (DID NOT USE), NOTED LAYER STRIPPING AS THE ATTACHED PHOTO SHOWS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11974607 ↗MalfunctionApr 27, 2021Device-Device Incompatibility; Device-Device Incompatibility
1) PLEASE VERIFY IF THERE WAS ANY INDICATION THE BROACH WAS A FACTOR? ANSWER: THERE IS INDICATION THAT THE BROACH WAS A FACTOR. WE HAVE SENT BACK BROACHES BEFORE TO TEST THEM WITH THE STEM AND THAT WASN'T AN ISSUE. 2) WAS THERE ANY OTHER ADVERSE CONSEQUENCES ASIDE FROM SURGICAL DELAY THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? ANSWER: THERE WERE NO OTHER CONSEQUENCES BESIDES A DELAY IN THE CASE AND AN ANGRY SURGEON. 3) IT WAS MENTION IN THE EVENT DESCRIPTION THAT YOU WILL ATTEMPT TO RETURNED THE PRODUCT. PLEASE SEND THE DEVICES TO THE ADDRESS BELOW AND KINDLY PROVIDE US THE TRACKING NUMBER ONCE THE PRODUCTS ARE SENT. ANSWER: I AM ATTEMPTING TO LOCATE THE IMPLANT AS IT WAS SENT DOWN TO BE WASHED IN SPD. NOW I AM HAVING ISSUES WITH LOCATING IT.
Patient problems: Insufficient Information
MAUDE report 11731785 ↗InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD PAIN. DOI: (B)(6) 2013. DOR: (B)(6) 2021; RIGHT HIP.
Patient problems: Pain
MAUDE report 11728508 ↗InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PRIMARY SURGERY WAS PERFORMED VIA BHA FOR THE RIGHT MEDIAL FEMORAL NECK FRACTURE ON AN UNKNOWN DATE. AFTER THE SURGERY, A SUPERFICIAL INFECTION WAS CONFIRMED AND THE HOSPITAL PLANNED AN REOPERATION ONLY FOR WASHING THE AREA. ON (B)(6) 2021, HOWEVER, DURING THE REOPERATION IT WAS FOUND THAT THE INFECTION HAD SPREAD TO A DEEPER AREA. THE SURGEON REMOVED THE IMPLANT AND PLACED A CEMENT MOLD WHICH CONTAINS ANTIBIOTICS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11568696 ↗InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS METALLOSIS AND POLYETHYLENE FAILURE. OPERATIVE NOTE REPORTED BARE BONE ON THE FEMORAL HEAD AND ACETABULUM WITH MARK OSTEOPHYTES ON THE ACETABULUM. ENCOUNTERED A BLACKISH SYNOVIAL FLUID, THERE WAS BLACK TISSUE IN THE TROCHANTERIC BURSA THESE WERE ALL REMOVE. SYNOVIUM WAS BLACKENED ANTERIORLY. SUPERIOR FRAGMENT HAD FRACTURED POLYTHENE. CLINICAL VISIT REPORTED PAIN, GRINDING WITH RANGE OF MOTION, DEPRESSION, ANXIETY, SLEEP DISORDER AND NUMBNESS. X-RAY REVEALED HAD SIGNIFICANT POLY WEAR OR POSSIBLE FRACTURE RIGHT HIP. ALLEGED ELEVATED METAL IONS HOWEVER COBALT AND CHROMIUM BLOOD RESULT SHOWS BELOW 7 PPB. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED IN THE MEDICAL RECORDS AND AFTER REVIEW THE PATIENT WAS REVISED TO ADDRESS GRINDING WITH ANY RANGE OF MOTION, NUMBNESS, DEPRESSION, ANXIETY, SLEEP DISORDER, TENDERNESS OVER THE GROIN, LIMITED RANGE OF MOTION.
Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Discomfort; Fall; Fatigue; Foreign Body Reaction; Inflammation; Loss of Range of Motion; Numbness; Pain; Pulmonary Embolism; Thrombosis/Thrombus; Unspecified Tissue Injury
MAUDE report 11164573 ↗InjuryDec 10, 2020Migration; Migration
ORIGINAL SURGERY DON (B)(6) 2020. RIGHT HIP REVISION. STEM SUBSIDED - FREQUENT DISLOCATIONS. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? --> UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> YES, WAS DEVICE EXPLANTED? --> FALSE, DID PATIENT REQUIRE REVISION SURGERY? --> FALSE, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.
Patient problems: Insufficient Information
MAUDE report 10983736 ↗InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESSED INFECTED RIGHT TOTAL HIP ARTHROPLASTY AND EXTENSIVE METALLOSIS/ALVAL REACTION FROM METAL ON METAL ARTICULATION WITH EXTENSIVE TISSUE INFLAMMATION. OPERATIVE FINDINGS THICK PURULENT MATERIAL ANTERIOR AND POSTERIOR HIPS, AS WELL AS OSTEOLYSIS AT THE PROXIMAL FEMUR AND ACETABULUM. ALSO INDICATED PAIN, DISCOMFORT AND SWELLING. A MODERATE AMOUNT OF BURSITIS, SYNOVITIS, BONE LOSS, DEBRIS AS WELL. LITIGATION ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: (B)(6) 2012 (RIGHT HIP).
Patient problems: Discomfort; Edema; Foreign Body Reaction; Inflammation; Injury; No Code Available; Osteolysis; Pain; Synovitis; Test Result; Unspecified Infection
MAUDE report 10740789 ↗InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDICAL RECORDS RECEIVED. ON (B)(6) 2020, THE OPERATIVE NOTED BLACK STAINING METAL DEBRIS WAS FOUND IN THE LINER.
Patient problems: Distress; Fatigue; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; No Code Available; Pain; Physical Asymmetry; Test Result
MAUDE report 10587646 ↗InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA BHA. ON (B)(6) 2020, THE PATIENT HAD A PAIN AND THE FEMORAL FRACTURE AROUND THE STEM WAS CONFIRMED BY X-RAY. THE STEM (P/N: 101204050) WAS PENETRATED LATERAL CORTICAL BONE. OPEN REDUCTION INTERNAL FIXATION SURGERY WAS PERFORMED FOR THE PATIENT¿S LEFT HIP JOINT. ON (B)(6) 2020. THE BIPOLAR CUP (P/N: 856749) AND THE HEAD (P/N: 136511000) AND THE STEM (P/N: 101204050) WERE REMAINED THE BODY BECAUSE THE REDUCTION AND THE FIXATION SUCCEED BY THE SURGERY. THE PATIENT HAD AN EXTRA INCISION DUE TO THIS EVENT. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. THE SURGEON COMMENTED THAT THE FRACTURE WAS A POSSIBLE COMPLICATION. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Bone Fracture(s); No Code Available; Pain
MAUDE report 9978954 ↗InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER RIGHT HIP ON OR ABOUT (B)(6) 2009. PATIENT EXPERIENCED PAIN AND SUFFERING; DISABILITY; IMPAIRMENT; LOSS OF FUNCTION, USE AND RANGE OF MOTION; DECREASED AND POOR HIP PERFORMANCE; GAIT DISTURBANCE; METALLIC AND OTHER PARTICULATE CONTAMINATION OF THE BLOOD AND BODY; EXACERBATION OF UNDERLYING HIP JOINT DISORDERS; INTERNAL SCARRING; AND IRRITATION AND INJURY TO THE TENDONS, LIGAMENTS, MUSCLES, BLOOD VESSELS, CARTILAGES, NERVES, BONES AND SOFT TISSUES OF THE HIP JOINT AND SURROUNDING AREAS. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT. THE PATIENT WAS REVISED DUE TO DISPLACED RIGHT HIP PROSTHESIS, AVULSED TOTAL HIP REPLACEMENT. OPERATIVE NOTE REPORTED HEMATOMA AROUND JOINT AND IMPLANT FOUND LATERALLY, CUP WAS LOOSE, FRACTURED BONE ON ACETABULUM AND WAS BROKEN OFF IN SEVERAL PIECES AND WERE REMOVED. THE REMAINDER OF THE ACETABULUM APPEARED BENIGN. THE HIP JOINT ABDUCTOR HAD BEEN DAMAGED. PATIENT SUFFERED ANEMIA DUE TO BLOOD LOSS. BLOOD TRANSFUSION AND FROZEN PLASMA WAS GIVEN TO THE PATIENT. DOI: (B)(6) 2009 - DOR: (B)(6) 2009 (RIGHT SIDE).
Patient problems: Adhesion(s); Anemia; Hematoma; Hemorrhage/Blood Loss/Bleeding; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Tissue Damage
MAUDE report 9699268 ↗MalfunctionFeb 6, 2020Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility
AFTER BROACHING TO A 5 THE DR SAID THE IMPLANT SAT A ¿HALF A CENTIMETER BELOW BROACH.¿
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9677969 ↗InjuryJan 3, 2020Loss of Osseointegration; Loss of Osseointegration
ORIGINAL SURGERY DONE (B)(6) 2017 . LEFT HIP REV REMOVED LINER, STEM & HEAD. PATIENT COMPLAINED OF PAIN, STEM WAS LOOSE.
Patient problems: Inadequate Osseointegration; No Code Available; Pain
MAUDE report 9545860 ↗InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LITIGATION RECORDS RECEIVED. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, RECORDS ALLEGES WEAKNESS AND DIFFICULTY WITH SIMPLE DAILY LIVING ACTIVITIES.
Patient problems: Ambulation or Postural Difficulties; Discomfort; Distress; Fatigue; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; No Code Available; Pain; Test Result
MAUDE report 9521417 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented devices
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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