TRI-LOCK GRIPTION 1012-14-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10603295001072), received between Aug 10, 2017 and Jun 25, 2025 — classified as 60 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REVISED DUE TO HIP PAIN. DOI: UNK. DOR: (B)(6) 2025. AFFECTED AREA: HIP LEFT.

  Patient problems: Pain

  MAUDE report 22331076 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP SURGERY (LEFT, FULL HIP) ON (B)(6) 2024. APPROXIMATELY 10 DAYS AFTER THE SURGERY PATIENT GOT FIRST INFECTION. SYMPTOMS WERE SWELLING, HIGH TEMPERATURE, SHIVERS, OOZING OF THE AREA. THE 2ND INFECTION CAME APPROX. 3 MONTHS AFTER SURGERY THE 3RD INFECTION OCCURRED ON (B)(6) 2025 WHERE PATIENT WAS ADMITTED TO HOSPITAL. THE 4TH INFECTION OCCURRED ON (B)(6) 2025 AND WAS TOLD PATIENT HAD SEPSIS/CELLULITIS. 5TH INFECTION ON (B)(6). IN ADDITION, PATIENT HEARS A CLICKING NOISE AND A PINCHING FEELING COMING FROM THE DEVICE. PATIENT IS OFF WORK SINCE THIS SURGERY.

  Patient problems: Cellulitis; Fever; Sepsis; Swelling/ Edema; Unspecified Infection

  MAUDE report 22044519 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAINFUL STEM. SURGEON REMOVED IT AND REPLACED THE STEM. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20532745 ↗
• MalfunctionNov 17, 2023Use of Device Problem; Osseointegration Problem; Use of Device Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON JUN 30, 2021, THE PRIMARY SURGERY WAS PERFORMED VIA THA FOR OA (OR OSTEONECROSIS) FOR THE RIGHT HIP JOINT WITH IMPLANTS IN QUESTION. ON (B)(6) 2023, X-RAYS SHOWED THAT THE STEM WAS IN A VARUS POSITION AND THERE WERE SIGNS OF LOOSENING. IN ADDITION, ALTHOUGH CLEARANCE WAS OBSERVED ON THE CUP SIDE WITH THE ACETABULUM BASE, IT COULD NOT BE DETERMINED WHETHER IT WAS CLEARLY LOOSE. REVISION SURGERY IS SCHEDULED FOR NOV 8, 2023. AT THAT TIME, THE SURGEON MENTIONED THAT THERE WAS A POSSIBILITY THAT THE CUP SIDE COULD BE SAVED. AS FOR THE CAUSE OF THE LOOSENING, IT WAS THOUGHT THAT THE STEM WAS PLACED IN A VARUS POSITION AND THE CUP WAS INSUFFICIENTLY INSERTED DURING THE PRIMARY SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18158400 ↗
• InjuryAug 14, 2023Material Deformation; Material Deformation

  HIP-TEP REVISION (STEM PLUS HEAD AND INSERT CHANGE) AFTER FRACTURE OF THE CERAMIC HEAD (BICYCLE CRASH TO THE LEFT HIP). STEM CHANGE DUE TO TAPER DESTRUCTION BY THE CERAMIC PARTICLES. DOI: (B)(6), 2015, DOE: (B)(6), 2023, AFFECTED SIDE: LEFT SIDE.

  Patient problems: Fall; Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 17539601 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION RECORD RECEIVED. THE LITIGATION ALLEGES ASR ALLEGES LEFT HIP PAIN, ELEVATED BLOOD METAL IONS, MEDICAL MONITORING, PHYSICAL VISITS, SUBSEQUENT SURGERIES, PAIN, AND SUFFERING. DOI: (B)(6) 2009; DOR: (B)(6) 2022; LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Depression; Extraskeletal ossification; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 17368443 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2013. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16914338 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, PROGRESS NOTES REPORTED THAT THE PATIENT EXPERIENCED LEFT KNEE PAIN AND HIP PAIN. ABOUT 2 WEEKS AGO PATIENT FELT POPPING IN LEFT HIP AREA AND CONSTANT PAIN IN EXTERNAL ROTATION. ON (B)(6) 2021 PATIENT HAD A BROKEN LEFT HIP PROSTHESIS. ON (B)(6) 2021, PATIENT UNDERGONE LEFT HIP REVISION. NO OPERATIVE NOTES PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Foreign Body Reaction; Joint Laxity; Metal Related Pathology; Pain; Pocket Erosion; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16226773 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 15 JUN 2022. AFTER REVIEW OF LITIGATION RECORDS, PLAINTIFF ALLEGES HEAVY METAL POISONING, PAIN, METALLOSIS, METAL WEAR, AND LIMITATION OF DAILY ACTIVITIES. DOI: (B)(6) 2009, DOR: (B)(6) 2020, UNKNOWN AFFECTED SIDE.

  Patient problems: Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 14875423 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PROXIMAL FEMORAL BONE FRACTURE. DOI: (B)(6) 2022; DOE: (B)(6) 2022; AFFECTED SIDE: LEFT SIDE.

  Patient problems: Limb Fracture

  MAUDE report 14166798 ↗
• InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES TOXIC LEVELS OF METAL IONS IN THE TISSUE, BONE, JOINT, BLOOD STREAM CAUSING DESTRUCTION, PAIN AND EMOTIONAL DISTRESS. DOI: (B)(6) 2008; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Foreign Body Reaction; Inflammation; Metal Related Pathology; Pain; Physical Asymmetry; Pocket Erosion; Unspecified Tissue Injury

  MAUDE report 13235260 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT HEMI HIP DONE ON (B)(6) 2019. THE PATIENT WAS DOING GREAT UNTIL SHE FEEL. THE SURGEON CALLED ME AND TOLD ME ABOUT THE PERPROSTALIC FRACTURE THAT HAD HAPPENED. HE WANTED TO REMOVE ALL THE IMPLANTS AND PUT IN A TOTAL HIP USING CORAIL REVISION AND PINNACLE DUAL MOBILITY. ALL IMPLANTS WERE REMOVED, THE NEW PARTS WERE PUT IN THE PATIENT AND THE FRACTURE WAS CABLED AND FIXED. THE SURGEON WAS HAPPY WITH THE LEG LENGTHS AND STABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2021. (LEFT HIP)

  Patient problems: Limb Fracture

  MAUDE report 12714784 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMPONENTS WERE REMOVED DUE TO INFECTION AND REPLACED WITH ANTIBIOTIC SPACER. DOI: (B)(6) 2021. DOR: (B)(6) 2021, UNK HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12656714 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON TUESDAY, (B)(6), AT (B)(6) HOSPITAL, DR. (B)(6) REVISED THE LEFT HIP OF A PATIENT WHO HAD A LEFT PRIMARY HIP ARTHROPLASTY IMPLANTED BY DR. (B)(6) AT (B)(6) HOSPITAL IN 2016. PATIENT PRESENTED IN DR. (B)(6) CLINIC WITH LEFT ANTERIOR THIGH PAIN. DR. (B)(6) ELECTED TO REMOVE THE SZ 5 TRILOCK BPS THAT WAS IN THE PATIENT TO TREAT FOR THE PAIN. DR. (B)(6) REMOVED THE 32 +9 BIOLOX DELTA FEMORAL HEAD WITH A TAMP. DR. (B)(6) THEN BEGAN REMOVING THE STEM USING A COMBINATION OF RIGID AND FLEXIBLE OSTEOTOMES AS WELL AS THE DEPUY SCREW IN FEMORAL STEM INSERTER AND ASSOCIATED SLAP HAMMER. WHILE TRYING TO REMOVE THE WELL FIXED FEMORAL STEM DR. (B)(6) FRACTURED THE PROXIMAL FEMUR. AS A RESULT, DR. (B)(6) CHOSE TO TREAT THE PATIENT WITH A COMPETITOR'S REVISION STEM. DR. (B)(6) REMOVED THE PRIMARY LINER AND REPLACE IT WITH A SZ 56X 36 +4 10 DEG ALTRX LINER TO HELP IMPROVE BIOMECHANICS. THERE WAS NO INDICATION BY ANYONE THAT THE PRODUCTS DID NOT PERFORM AS EXPECTED. NO INSTRUMENTATION BROKE DURING THE CASE. THERE WAS NO LOOSENING OF ANY COMPONENTS. DOI: 2016. DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Pain

  MAUDE report 12474680 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 11744916 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL RIGHT HIP. METAL ON METAL. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2006. DOR: (B)(6) 2021; HIP UNKNOWN.

  Patient problems: Pain

  MAUDE report 11495509 ↗
• MalfunctionMar 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRILOCK STEM DID IMPLANT TO LEVEL OF CORRESPONDING SIZE BROACH (STEM DIDN'T GO DOWN). IT WAS ALSO REPORTED OF A 5 MINUTES SURGICAL TIME EXTENSION.

  Patient problems: Insufficient Information

  MAUDE report 11463344 ↗
• InjuryFeb 23, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2018 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 11367072 ↗
• InjuryJan 11, 2021Degraded; Degraded

  THE PATIENT MADE AN APPOINTMENT TO HIS DOCTOR AFTER NOTICING A BUMP ON HIS THIGH. DURING THE SURGERY, PSEUDOTUMORS WERE REMOVED. DOI: (B)(6) 2010, DOR: (B)(6) 2018, RIGHT HIP.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11146765 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM ALLEGES ELEVATED METAL IONS AND INFECTION. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS INFECTED RIGHT TOTAL HIP REPLACEMENT. REVISION NOTES REPORTED A SEPTIC WITH INFECTED RIGHT HIP AND POSITIVE BLOOD CULTURES. THERE WAS MORE PURULENT MATERIAL. THE REMAINDER OF THE HIP DID SHOW A LOT OF HEMATOMA. 4 UNITS OF BLOOD GIVEN FOR THE INTRAOP BLOOD LOSS AS WELL AS THE PREOP ANEMIA. SURGICAL PATHOLOGY REPORTED OF ACUTE INFLAMMATION, DOI: (B)(6) 2008; DOR: (B)(6) 2019 (RIGHT HIP). 2ND STAGE REVISION WAS PERFORMED ON (B)(6) 2019 FOR THE REMOVAL OF CEMENT SPACER, CONVERSION TO TOTAL HIP REPLACEMENT.

  Patient problems: Anemia; Hematoma; Hemorrhage/Blood Loss/Bleeding; Inflammation; No Code Available; Test Result; Unspecified Infection

  MAUDE report 10241969 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MOM LINER EXCHANGE DUE TO PAINFUL HIP. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS THE PAINFUL RIGHT HIP REPLACEMENT WITH METAL REACTION AND ELEVATED METAL LEVELS. OPERATIVE NOTE INDICATED THAT THERE WAS A SCAR TISSUE AROUND THE HIP JOINT AND LOT OF TISSUE THAT WAS BRAWNY AND RED AND CONSISTENT WITH THE METALLOSIS REACTION WITH SOME METAL DISCOLORATION. MRI SHOWS ADVERSE LOCAL SOFT TISSUE REACTION WITH A LARGE JOINT EFFUSION AND BONE MARROW EDEMA CHANGES. THE STEM WAS ADDED TO THE IMPACTED PRODUCT DUE TO ELEVATED METAL LEVEL.

  Patient problems: Adhesion(s); Edema; Foreign Body Reaction; No Code Available; Pain; Test Result

  MAUDE report 10209078 ↗
• MalfunctionJun 5, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE TRILOCK STEM WITHIN THE STERILE PACKAGING HAS A WHITE PARTICULATE ON THE GRIPTION BLAST. SURGEON SAID IT FELT LIKE A DIFFERENT MATERIAL THAN THE FOAM BARREL PLACED OVER THE TRUNNION. SURGEON REQUESTED A NEW STEM WITHOUT REMOVING FROM THE STEM PACKAGING SLEEVE. SURGERY DELAY: 2 MIN.

  Patient problems: No Code Available

  MAUDE report 10123140 ↗
• InjuryMay 19, 2020Degraded; Degraded

  LITIGATION PAPERS ALLEGE PAIN, STIFFNESS, DISCOMFORT, WEAKNESS AND EXCESSIVE METAL ION LEVELS. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR FAILED LEFT TOTAL HIP ARTHROPLASTY. IT WAS INDICATED THAT THE PATIENT DEVELOPED SLIGHT ELEVATION OF HIS COBALT CHROME LEVELS AND HAD SOME SYMPTOMS THAT WERE SLOWLY PROGRESSIVE OVER THE YEARS AND HIS COBALT CHROME LEVEL IS RISING. OPERATIVE NOTES REPORTED THAT THERE WAS A SMALL AMOUNT OF GRAY TINGED AND BROWNISH TINGED SYNOVIAL FLUID. THERE WAS SOME GRANULATION TISSUE. THE TRUNNION HAD VERY SMALL AMOUNT OF BLACK OXIDATION. THERE WAS SOME SUPERIOR AND ANTERIOR BONE LOSS. THE ANTERIOR BONE LOSS WAS DUE TO A BED OF INFLAMMATORY OSTEOLYSIS. ADDED PATIENT AGE AND MEDICAL HISTORY ASR LITIGATION ALLEGES INJURY, LIMITED MOBILITY AND ANXIETY.

  Patient problems: Anxiety; Discomfort; Foreign Body Reaction; Inflammation; Injury; Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Osteolysis; Pain; Test Result; Tissue Damage

  MAUDE report 10072894 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEING REVISED FOR SINGLE STAGE INFECTION WASH-OUT/ IRRIGATION AND DEBRIDEMENT. ALL IMPLANTS WERE REMOVED. CULTURES WERE TAKEN AND SENT TO LAB, NO RESULTS KNOWN. PUSS WAS SEEN AT INCISION. GREATER TROCHANTER WAS FRACTURED DURING REMOVAL OF STEM. NEW PINNACLE CUP/ LINE/ SUMMIT STEM AND CERAMIC HEAD WERE IMPLANTED. FRACTURED FIXED WITH SYNTHES TROCH PLATE AND CABLES. DOI: (B)(6) 2020. DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Bone Fracture(s); No Code Available; Unspecified Infection

  MAUDE report 9874144 ↗
• InjuryMar 24, 2020Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  UNF AND MEDICAL RECORDS RECEIVED. AFTER A REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS THE SUBSIDENCE OF THE TRI-LOCK STEM. REVISION OPERATIVE NOTE REPORTED A SLIGHT AMOUNT OF MICROMOTION OF THE FEMORAL COMPONENT INDICATIVE OF A LACK OF BONE INGROWTH. SOFT TISSUE SCAR ON THE MOUTH OF THE PROXIMAL FEMUR WAS DEBRIDED SHARPLY. ONLY THE HEAD AND STEM WAS REVISED. DOI: (B)(6) 2017. DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Scar Tissue

  MAUDE report 9871900 ↗