TRI-LOCK GRIPTION 1012-04-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10603295000754), received between Dec 21, 2016 and Sep 26, 2023 — classified as 46 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 54 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL, FRACTURING HER FEMUR AROUND THE HIP STEM. SURGEON REMOVED THE STEM AND IMPLANTED A LONG STEM WITH A NEW HEAD. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2014. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 17817465 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS METALLOSIS, PSEUDOTUMOR AND PERSISTENT PAIN. OPERATIVE NOTE REPORTED THERE WAS TRUNNIONOSIS THAT WAS DEBRIDED IN THE TRUNNION HOWEVER IN GOOD SHAPE. THERE WAS A LARGE PSEUDOTUMOR, SUBSTANTIAL EVIDENCE OF METALLOSIS INSIDE THE FEMORAL HEAD THIS WAS DEBRIDED. THERE WAS SOFT TISSUE EROSION BUT ABDUCTORS WERE INTACT. DOI: (B)(6) 2009; DOR: (B)(6) 2023; RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Pocket Erosion

  MAUDE report 16253601 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE IN FEMUR. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 15959317 ↗
• MalfunctionJul 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STEM SAT UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093564 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PERIPROSTHETIC FRACTURE. REMOVED STEM AND HEAD. REPAIRED FRACTURE AND REPLACED STEM AND HEAD. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: (B)(6), 2022. DOR: (B)(6), 2022 AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 14474857 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION COMPLAINT RECEIVED AD (B)(6) 2022. PATIENT WAS REVISED WAS DUE TO HEAVY METAL POISONING FROM TOXIC HEAVY METALS. ALSO ALLEGES PAIN, INJURY, METAL STAINED TISSUE, METAL WEAR, LOSS OF ENJOYMENT OF LIFE, LIMITATION OF DAILY ACTIVITIES, EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6) 2011. DOR: (B)(6) 2021. UNKNOWN HIP.

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Fatigue; Foreign Body Reaction; Hearing Impairment; Hypersensitivity/Allergic reaction; Inflammation; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Numbness; Pain

  MAUDE report 14111236 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. THE PATIENT WAS IMPLANTED WITH PINNACLE MOM AND TRILOCK STEM. THE PATIENT HAD LEFT HIP JOINT CAPSULAR SYNOVITIS AND PSEUDOTUMOR AND FLUID COLLECTION. PAIN IS ACCOMPANIED BY INSTABILITY, NUMBNESS AND WEAKNESS, EROSION, GLUT MEDIUS TENDONITIS, AND PAIN WITH RESISTED ABDUCTION, SWELLING, AND LOSS OF MOTION, THE PAIN INCREASED WHEN WALKING, WITH BURNING AND NUMBNESS IN THE ANTEROLATERAL THIGH AND LEFT GREATER THAN RIGHT, POSSIBLE LUCENCY AND BONE LYSIS.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Extraskeletal ossification; Fall; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Numbness; Osteolysis; Pain; Physical Asymmetry; Pocket Erosion; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 13043886 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORDS RECEIVED. LITIGATION REPORTED THAT PATIENT COMPLAINTS OF DIFFICULTY WALKING, DISABILITY AND PAIN. IT WAS REPORTED ALSO THE PATIENT WAS REVISED FOR FAILED ACETABULAR COMPONENT. DOI: (B)(6) 2014, DOR: (B)(6) 2018, RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 12834788 ↗
• InjuryOct 13, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THERE WAS A LEFT HIP REVISION DUE TO LOOSENING - REMOVED CATHCART, HEAD AND STEM. DOI: (B)(6) 2021, DOR: (B)(6) 2021.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12627658 ↗
• MalfunctionSep 20, 2021Migration; Migration

  IT WAS REPORTED THAT IN (B)(6) 2018, THE PATIENT FELL FROM A TRUCK BED AND FRACTURED HIS FEMORAL NECK AND UNDERWENT THE BHA SURGERY WITH THE STEM. THE DATE OF FALL AND THE SURGERY IS UNKNOWN. AFTER THE SURGERY, THE PATIENT COMPLAINED OF PAIN DURING HOSPITALIZATION, BUT WAS DISCHARGED FROM THE HOSPITAL. AFTER THAT, ALTHOUGH THE PATIENT WAS FOLLOWED REGULARLY, BUT THE OCCURRENCE OF MIGRATION OF THE STEM HAD NOT BEEN NOTICED, AND THE SURGEON FOUND THE MIGRATION OF THE STEM AT THE LATEST MEDICAL EXAMINATION. X-RAY SHOWED THAT MIGRATION HAD BEEN CONSIDERABLY PROGRESSING FROM 1 YEAR AGO. THE SURGEON SAID THAT MIGRATION MIGHT HAVE PROGRESSED QUICKLY BECAUSE THE PATIENT WAS STILL VERY ACTIVE, SUCH AS LOADING AND UNLOADING TRUCKS, AND HE IS STILL IN HIS 50S. IN ADDITION, THE BONE ON THE GREATER TROCHANTER SIDE OF THE STEM HAS DISSOLVED, AND INFECTION IS SUSPECTED. THE REVISION SURGERY VIA THA IS SCHEDULED ON (B)(6) 2021.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12495501 ↗
• InjuryAug 30, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INCREASING HIP PAIN AND INSTABILITY. TRILOCK STEM IS NOTED TO HAVE SUBSIDED AT SOME POINT IN TIME. STEM WAS WELL FIXED AND DIFFICULT TO REMOVE. 40MM +5 METAL HEAD WAS ALSO EXPLAINED (PRODUCT AND LOT NUMBERS COULD NOT BE DISCERNED). CUP AND LINER REMINDER INSITU. DOI: (B)(6) 2008, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12384224 ↗
• MalfunctionFeb 23, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE SURGEON BROACHED UP TO A 4 BROACH AND IMPLANTED A SIZE 4 TRILOCK STD. IT SAT PROUD AND AFTER REBROACHING IT STILL SAT PROUD. HE THEN REMOVED THE STEM, REBROACHING AGAIN AND WE OPENED A NEW SIZE 4 STD TRILOCK. THIS DELAYED THE CASE ABOUT 5-10 MINUTES BUT WAS NOT DETRIMENTAL TO THE OUTCOME OF THE CASE. THE OPERATIVE SIDE WAS THE RIGHT HIP. I SENT THE IMPLANT TO SPD TO BE STERILIZED AND I WILL ATTEMPT TO RETURN IT. IMPLANT- TRILOCK SIZE 4 STD 101204040 LOT- J04A41. DOE: (B)(6) 2021, RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11365735 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SEVERE HETEROTOPIC OSSIFICATION SO HE REMOVED THE HEAD AND LINER TO HAVE BETTER ACCESS TO THE HIP TO REMOVE AS MUCH ABNORMAL BONE GROWTH AS HE COULD. HE REMOVED THE STEM ALSO AND REPLACED WITH STEM/HEAD WITH A COMPETING PRODUCT. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT SIDE.

  Patient problems: No Code Available

  MAUDE report 10224532 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A RIGHT HIP REPLACEMENT. SHE HAD EXPERIENCED LOTS OF PAIN, RIGHT THIGH SLIPS AND SCARED OF FALLING. SHE RECEIVED ANOTHER CORTISONE IN DEC WHICH DID NOT HELP. PATIENT PROVIDED HER PHONE AND HOME NUMBER AND LOOKING FORWARD FOR A RESPONSE. THERE WAS NO REVISION SURGERY REPORTED. DOI: (B)(6) 2018; DOR: NONE REVISED (RIGHT HIP).

  Patient problems: No Code Available; Pain

  MAUDE report 9727784 ↗
• InjuryFeb 18, 2020Corroded; Degraded; Corroded; Degraded

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT COMPLAINED OF PAIN AND DISABILITY. THEN WAS REVISED FOR MECHANICAL PROBLEMS RIGHT HIP PROSTHESIS. IT WAS INDICATED THAT THE COBALT/CHROMIUM SERUM LEVELS REVEALED SIGNIFICANT ELEVATION OF THE COBALT LEVEL CONSISTENT WITH TRUNNIONOSIS. IMAGING REVEALED WELL FIXED IMPLANTS BUT EVIDENCE OF MILD PERIPHERAL OSTEOLYSIS IN THE SUPERIOR LATERAL ACETABULUM. THE PATIENT IS UNDERGOING HIP REVISION SURGERY TO TREAT THE PAIN AND METALOSIS. OPERATIVE NOTES REPORTED THAT INSPECTION OF THE TRUNNION REVEALED SIGNIFICANT METALOSIS AND CORROSION. DOI: (B)(6) 2010; DOR: (B)(6) 2018; LEFT HIP. THE PATIENT HAS BILATERAL HIP IMPLANTS, PLEASE SEE (B)(4) FOR THE RIGHT HIP.

  Patient problems: Foreign Body Reaction; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 9720724 ↗
• InjuryFeb 17, 2020Degraded; Degraded

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT COMPLAINED OF PAIN AND DISABILITY. THEN WAS REVISED FOR MECHANICAL PROBLEMS, RIGHT HIP PROSTHESIS. IT WAS INDICATED THAT THE COBALT/CHROMIUM SERUM LEVELS REVEALED SIGNIFICANT ELEVATION OF THE COBALT LEVEL CONSISTENT WITH TRUNIONOSIS. IMAGING REVEALED WELL-FIXED IMPLANTS BUT EVIDENCE OF MILD PERIPHERAL OSTEOLYSIS IN THE SUPERIOR LATERAL ACETABULUM. NO LABS PROVIDED FOR THE ALLEGED ELEVATED METAL IONS. THE PATIENT HAS BILATERAL HIP IMPLANTS. (B)(4) FOR THE LEFT HIP.

  Patient problems: Foreign Body Reaction; No Code Available; Osteolysis; Pain

  MAUDE report 9717790 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE ASR CUP ROTATED OUT OF POSITION, LARGE PSUEDOTUMOR, DEHISCENCE, 2/3 OF THE ABDUCTORS WERE DETACHED, METALLIC DEBRIS, PROTRUSION ACETABULI, METALLOSIS, DROPFOOT, WEAKNESS, PAIN, DISCOMFORT, SCARRING, AND OTHER PAIN, EMOTIONAL AND PHYSICAL SUFFERING.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Cyst(s); Discomfort; Distress; Edema; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Impaired Healing; No Code Available; Pain; Swelling/ Edema; Tissue Damage; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 9490548 ↗
• InjuryAug 22, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS PERI PROSTHETIC FRACTURE OF RIGHT HIP AND LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2016; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; No Code Available

  MAUDE report 8921990 ↗
• MalfunctionJul 23, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE TRILOCK FEMORAL STEM, SIZE 4 LOT # HR3366, IS NOT GOOD SIZE. THERE IS A MANUFACTURING DEFECT. CAT # 101204040, GRM: 88363. THE CMDSNET REPORT NUMBER IS: (B)(4), STEM SZ 4 STD OFFSET TRILOCK HIP - AH# (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8816722 ↗
• InjuryJul 17, 2019Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  THE THA SURGERY PERFORMED ON (B)(6) 2019. IT WAS REPORTED THAT IT WAS DETECTED THAT A FRACTURE AROUND THE STEM (P/N: 101204040) AND SINKING THE STEM WHEN THE PATIENT COMPLAINED THE PAIN AFTER THE THA SURGERY. ALTHOUGH THERE WAS A POSSIBILITY FOR THE REVISION SURGERY TO BE PREFORMED BY REPLACING THE STEM OR WIRING THE FEMUR, THERE WAS NO INFORMATION ABOUT ADDITIONAL SURGERY AT THE TIME OF (B)(6) 2019. AS DR¿S VIEW: IT WAS CONSIDERED THAT THE CAUSE OF FRACTURE OCCURRENCE WAS THE STEM WAS MIGHT BE TOO BIGGER THAN THE TRI-LOCK BROACH WHEN COMPARED. POSSIBLE CAUSE: THERE WAS A POSSIBILITY THAT THE PATIENT'S FEMUR WAS ORIGINALLY VULNERABLE DUE TO OSTEOPOROSIS AND THE LIKE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 8798601 ↗
• MalfunctionJun 17, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  WHILE SURGEON WAS TRYING TO PUT THE FEMORAL STEM IN THE FEMORAL CANAL, THE IMPLANT SAT TOO TALL VERSUS THE BROACH. SURGEON BROACHED UNTIL RASP 4, PUT A 4 STANDARD IMPLANT, AND THE STEM WAS 6 MM HIGHER THAN THE TRIAL. THE SURGEON REMOVED THE IMPLANT WITH A SLAP HAMMER, REAMED AGAIN WITH BROACH SIZE 4, TRIED TO PUT BACK THE FEMORAL STEM SIZE 4 IN THE CANAL, AND WAS STILL PROUD OF 6 MM. HE THEN REMOVED THE STEM, AND ASK FOR AN OTHER SIZE 4.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8703548 ↗
• MalfunctionJun 12, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  STEM SAT HIGHER/ELEVATED. DR WANTS TO SEND BACK 4 BROACH AND 4 BPS STEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8691316 ↗
• InjuryMay 9, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  BILATERAL PATIENT. LITIGATION ALLEGES THAT DUE TO METALLOSIS AND FAILURE OF OSSEOINTEGRATION OF THE PINNACLE DEVICE, PATIENT UNDERWENT REVISION ON BOTH SIDES. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES COMPONENT FRACTURE, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: (B)(6) 2012 (LEFT HIP).

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8594787 ↗
• InjuryFeb 28, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TRILOCK BPS AT BONE TO IMPLANT INTERFACE. PATIENT IS RHEUMATOID, DOI: (B)(6) 2014. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8379400 ↗
• InjuryFeb 27, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  UPDATE: 10/14/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. UPDATE REC'D (B)(6) 2014- PATIENT WAS REVISED TO ADDRESS PAIN. THE COMPLAINT WAS UPDATED ON: 04/30/2014. UPDATE AD 08 JUN 2018 RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8373429 ↗