TRI-LOCK GRIPTION 1012-14-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10603295001089), received between Sep 22, 2017 and Apr 1, 2026 — classified as 56 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Degraded” (10 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Fracture

  IT WAS REPORTED THAT PATIENT WAS MAKING HIS BED AND THE STEM BROKE. REQUIRING A REVISION TOTAL HIP ARTHROPLASTY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24756044 ↗
• InjuryAug 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A HEMIARTHROPLASTY WAS REVISED TO A TOTAL HIP ARTHROPLASTY. THE SURGEON WHO PERFORMED THE REVISION SAID THAT THE STEM IMPLANT WAS IMPLANTED INCORRECTLY AND THAT WAS CAUSING DISLOCATION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22715716 ↗
• InjuryJul 31, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT WAS HEMIARTHROPLASTY REVISED TO A TOTAL HIP ARTHROPLASTY. THE SURGEON STATED THAT WHEN THE DEVICE WERE INITIALLY IMPLANTED, BY ANOTHER SURGEON, THE STEM WAS ANTEVERTED WHICH WAS CAUSING THE BIPOLAR CONSTRUCT TO DISLOCATE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22674527 ↗
• InjuryApr 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSE TRILOCK. REVISED TO RECLAIM. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19190969 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HIP FRACTURE DUE TO FALL. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 18307674 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2022, ONE MONTH FOLLOWING THE REVISION SURGERY DUE TO THE FAILED DEPUY ASR PROSTHESIS, THE PATIENT SUFFERED AN INFECTION AND INFLAMMATORY REACTION REQUIRING IRRIGATION AND DEBRIDEMENT. FOLLOWING THE REVISION, THE PATIENT HAD PAIN IN THE AREA NEAR THE INCISION. FROM (B)(6) 2022 TO (B)(6) 2023, THE PATIENT WAS ALSO TESTED TWICE REGARDING HIS INFLAMMATION LEVELS WHICH THE PATIENT STILL HAS. THE PATIENT HAS BEEN ADVISED THAT HIS INCREASED INFLAMMATION IS NOT DISEASE-RELATED. DOI: (B)(6) 2009 (STEM), DOI: (B)(6) 2022 (BI-MENTUM LINER(2), CUP, AND HEAD), DOE: (B)(6) 2022, LEFT HIP.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 18056116 ↗
• InjuryJun 5, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  LH WAS A RECIPIENT OF DEPUY HIP REPLACEMENT (B)(6) 2009. HE JUST HAD A REVISION AND WAS TOLD TO CONTACT YOU REGARDING THIS MATTER. DOI: (B)(6) 2009; DOR: UNKNOWN; UNKNOWN AFFECTED HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 17062385 ↗
• InjuryJan 5, 2023Degraded; Degraded

  PATIENT UNDERWENT PRIMARY THR WHERE A TRILOCK STEM AND DELTA MOTION ACETABULAR CUP WAS UTILIZED. PATIENT HAS PRESENTED WITH HIP PAIN. IMAGES ATTACHED SHOW METALOSIS. ON OPENING THE HIP, THE TAPER ON THE STEM WAS FOUND TO BE DAMAGED (TUNIONOSIS?). QUOTE ON SURGEONS TEXT MESSAGE AS I WAS NOT PRESENT ¿WAS THE TRUNION. WAS DAMAGED WITH A WELL FIXED STEM. DISASTER¿. DELTA MOTION ACETABULAR COMPONENT AND TRILOCK STEM WERE REMOVED AND A ZIMMERBIOMET IMPLANT IMPLANTED. NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 16101728 ↗
• InjuryNov 28, 2022Degraded; Degraded

  ASR LITIGATION RECORD RECEIVED. ON (B)(6) 2022 LITIGATION ALLEGES THAT PATIENT HAD SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT, SEVERE PAIN AND DISCOMFORT, INCREASED METAL LEVELS IN BLOOD INCLUDING COBALT AND CHROMIUM; PERMANENT INJURIES, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT; ECONOMIC DAMAGES INCLUDING MEDICAL AND HOSPITAL EXPENSES FOR REVISION SURGERY FOLLOWED BY MONITORING, REHABILITATION AND PHARMACEUTICAL COSTS. DOI: (B)(6) 2009. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Physical Asymmetry; Swelling/ Edema; Synovitis

  MAUDE report 15868644 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FELL 3 WEEKS POST SURGERY RESULTING IN A PERIPROSTHETIC FRACTURE. A LONGER REVISION STEM WAS NEEDED TO SURPASS THE FRACTURE. ORIGINAL IMPLANT DATE UNKNOWN. LOOSENING WAS REPORTED UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 15614438 ↗
• InjuryFeb 23, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WAS DUE TO METAL POISONING FROM TOXIC HEAVY METALS RELEASED. RECORDS ALSO ALLEGES PAIN, METAL WEAR, INJURY SCAR TISSUE FORMATION AND LIMITATION OF DAILY ACTIVITIES. DOI: (B)(6) 2009; DOR: (B)(6) 2021 UNK HIP.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue

  MAUDE report 13584714 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 13342904 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS REVIEWED: LITIGATION PFS ALLEGES BACK, GROIN AND HIP PAIN; INABILITY TO WALK FOR MORE THAN ¼ MILE WITHOUT HAVING TO SIT DUE TO PAIN; HIGH METAL ION CONTENT; HEARING LOSS; RINGING IN EARS; DRY MOUTH AND EYES, BEGINNING IN 2019. ON (B)(6) 2005, PRIMARY RIGHT TOTAL HIP REPLACEMENT PERFORMED TO ADDRESS DEGENERATIVE ARTHRITIS. DEPUY PINNACLE METAL-ON-METAL UNCEMENTED HIP REPLACEMENT WITH AML PRESS-FIT STEM IMPLANTED WITHOUT COMPLICATIONS. IMPLANT LOG STICKER SHEET FOR PRIMARY RIGHT HIP PROCEDURE ON PAGE 31 OF RECORDS. ON (B)(6) 2009, PATIENT RECEIVED A LEFT TOTAL HIP REPLACEMENT PERFORMED TO ADDRESS DEGENERATIVE ARTHRITIS. DEPUY PINNACLE METAL-ON-METAL UNCEMENTED HIP REPLACEMENT WITH TRILOCK PRESS-FIT STEM IMPLANTED, WITHOUT INTRAOPERATIVE COMPLICATIONS. PATIENT REPORTEDLY HAD A NORMAL BLOOD LOSS CONSISTENT WITH POST-OP HIP REPLACEMENT, BUT EXPERIENCED AN ACUTE DROP OF HIS HEMATOCRIT, BUT REMAINED HEMODYNAMICALLY STABLE WITHOUT ANY REPORTED INTERVENTIONS. HE HAD POST-OPERATIVE ATELECTASIS WHICH HE RECOVERED FROM WITH "APPROPRIATE PULMONARY CARE AND INCENTIVE SPIROMETRY". ON (B)(6) 2020 LAB RESULT COBALT, PLASMA 4.5 UG/L HIGH RESULT. ON (B)(6) 2020, PATIENT ADMITTED FOR R

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Hearing Impairment; Limb Fracture; Swelling/ Edema; Synovitis

  MAUDE report 12933971 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL HIP DONE BY DR. LYNCH. THE PATIENT HAS A PERIPROSTHETIC FRACTURE OF THE FEMUR, UNKNOWN CAUSE. THE SURGEON REMOVED THE FEMORAL COMPONENT AND LINER. THE CUP WAS RETAINED. THE SURGEON REPAIRED THE FEMORAL FRACTURE AND USED A NEW FEMORAL COMPONENT. DOI: (B)(6) 2021; DOR: (B)(6) 2021; (LEFT HIP).

  Patient problems: Limb Fracture

  MAUDE report 12358871 ↗
• MalfunctionDec 17, 2020Inadequacy of Device Shape and/or Size; Device-Device Incompatibility; Inadequacy of Device Shape and/or Size; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STEM DID NOT IMPLANT TO THE LEVEL OF THE SAME SIZE BROACH. IMPLANT DID NOT MATCH BROACH. THERE WAS A SURGICAL DELAY OF 3 MINUTES. DOE: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11028290 ↗
• InjuryNov 12, 2020Degraded; Degraded

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED MILD TO MODERATE ADVERSE LOCAL TISSUE RESPONSE WITH NO FRANK NECROSIS OF TISSUES OUTSIDE OF THE JOINT NOR PSEUDOTUMOR FORMATION. OPERATIVE NOTES INDICATED PAIN, ELEVATED CHROMIUM AND COBALT LEVELS, TAPER OF THE HEAD ON TO THE TRUNNION HAD QUITE A BIT OF CORROSION. DOI: (B)(6) 2008 - DOR: (B)(6) 2020 (RIGHT HIP).

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

  MAUDE report 10829190 ↗
• InjuryNov 10, 2020Corroded; Degraded; Corroded; Degraded

  UNF AND MEDICAL RECORDS RECEIVED. PINNACLE CLAIM SUBMISSION FORM ALLEGES ELEVATED METAL IONS AND METALLOSIS/METAL WEAR. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS FAILED RIGHT TOTAL HIP REPLACEMENT. REVISION NOTES REPORTED THAT WE CLEARLY NOTED THAT THE SOFT TISSUE LINING THE HIP MIGHT HAVE SLIGHTLY DARKENED FROM METAL WEAR, BUT THAT SIGNIFICANTLY WAS FAR FROM BLACK. WE DID HAVE CORROSION AT THE TRUNNION. WE WERE ABLE TO EXPLANT THE SIZE 40 DIAMETER FEMORAL HEAD, IMMEDIATELY NOTED THE TRUNNION HAD MILD CORROSION. DOI: (B)(6) 2008. DOR: (B)(6) 2020; (RIGHT HIP).

  Patient problems: Foreign Body In Patient; Metal Related Pathology; No Code Available; Test Result

  MAUDE report 10818708 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT ALLEGED ELEVATED CHROMIUM LEVEL. DOI: (B)(6) 2010. DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: No Code Available; Test Result

  MAUDE report 9916901 ↗
• InjuryMar 11, 2020Loss of Osseointegration; Loss of Osseointegration

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS MECHANICAL LOOSENING OF THE STEM AND PAIN. THE LOOSENING OF THE STEM WAS BASED ON THE RADIOGRAPHS SHOWING A HINT OF A RADIOLUCENT LINE THAT APPEARED TO BE CIRCUMFERENTIAL AROUND THE FEMORAL STEM. THERE WERE NO FURTHER NOTES AVAILABLE TO CONFIRM THE SUSPECTED LOOSENING. FEMORAL STEM, HEAD AND LINER WERE REVISED. ADMISSION HISTORY NOTES INDICATE HISTORY OF FALL IN THE LAST 6 MONTHS PRIOR TO THE REVISION. DOI: (B)(6) 2009, DOR: (B)(6) 2010, (LEFT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9819317 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS MOM PAIN. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, LITIGATION RECORDS ALLEGES METALLOSIS AND LOSS OF HEARING. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR FAILURE OF TOTAL HIP WITH PAIN, ONE EPISODE OF DISLOCATION, METAL-METAL PROBLEMS WITH ELEVATED COBALT AND CHROMIUM LEVELS, PSUEDOCYST FORMATION. OPERATIVE NOTES REPORTED THAT THERE WERE EGRESS OF BLACK THIN FLUID. THE LINER WAS NOT CONCENTRICALLY REDUCED AND WAS ASKEW IN RELATIVE TO THE RETROVERSION TO THE CUP. FINDINGS REPORTED OF HYPERTROPHIC SYNOVITIS DUE TO METAL DEBRIS. STEM HAS BEEN ADDED TO THE COMPLAINT.

  Patient problems: Cyst(s); Foreign Body Reaction; Hearing Impairment; Hypersensitivity/Allergic reaction; No Code Available; Pain; Synovitis

  MAUDE report 9771179 ↗
• InjuryJan 16, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT METAL ON METAL REVISED TO CERAMIC ON POLY. DOI: (B)(6) 2008; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Hypoesthesia; Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain; Weakness

  MAUDE report 9595960 ↗
• InjuryDec 4, 2019Degraded; Degraded

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE UNKNOWN. METAL ION LEVELS WERE CO 24 CR 3.3, PATIENT WAS NOT VERY SYMPTOMATIC. PATIENT HAD A LITTLE BIT OF GROIN PAIN. DR SAID THERE WAS SOME WEIRD LOOKING TISSUE MAYBE A LITTLE BIT OF A PSEUDOTUMOR. THERE WAS CORROSION AT THE HEAD NECK TAPER JUNCTION. CUP WAS REMOVED AND A ZIMMER CUP WAS IMPLANTED WITH A POLY LINER. STEM WAS WELL FIXED AND LEFT IN, A 36+5 TS CERAMIC HEAD WAS PUT IN THE STEM. THIS IS ALL THE INFORMATION I HAVE. DOI: UNKNOWN; DOIR: (B)(6) 2019; LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Pain; Test Result

  MAUDE report 9413229 ↗
• InjuryNov 15, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES PAIN AND DISCOMFORT. UPDATE AD 22 OCT 2019. COM-(B)(4) HAS BEEN REOPENED UNDER PC-(B)(4) DUE TO RECEIPT OF PPF AND MEDICAL RECORDS VIA CD SHIPMENT LAST 15 NOV 2018. PPF ALLEGES LOOSENING OF THE STEM AND INDICATES THAT A REVISION HAS OCCURRED. AFTER REVIEW OF MEDICAL RECORDS, THERE WERE NO REVISION OPERATIVE NOTES PROVIDED. DOI: (B)(6) 2010 - DOR: (B)(6) 2013 (LEFT HIP). PATIENT IS BILATERAL. SEE PC-(B)(4) FOR THE LEFT HIP.

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9330032 ↗
• InjuryNov 1, 2019Migration; Migration

  IT WAS REPORTED THAT THE STEM WAS REVISED FOR SUBSIDENCE PATIENT HIP WAS TOO SHORT. DOI: (B)(6) 2019. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9265858 ↗
• InjuryOct 8, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LEFT HIP PAIN AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. THE PATIENT HAD A TOTAL HIP REPLACEMENT DONE AT (B)(6) HOSPITAL ON (B)(6) 2017. THE SURGEON OPENED THE LEFT HIP CAPSULE, SENT TISSUE AND FLUID SPECIMENS TO THE LAB, AND CONTINUED REMOVING THE DEPUY FEMORAL HEAD, POLY LINER, AND FINALLY, THE TRILOCK STEM LEAVING THE CUP INTACT, IN THE ACETABULUM. THE STEM SHOWED ONLY A BIT OF INGROWTH AND SURGEON SUSPECTED THAT TO BE THE CAUSE OF THE PAIN. THE LAB REPORTS CAME BACK NEGATIVE FOR INFECTION. THE SURGEON IMPLANTED A NEW COMPETITOR STEM, A NEW DEPUY POLY LINER AND COMPETITOR FEMORAL HEAD, WASHED THE JOINT OUT WITH COPIOUS AMOUNTS OF ANTIBIOTIC SALINE IRRIGATION, AND AFTER ONE LAST RANGE-OF-MOTION EXERCISE, CLOSED THE WOUND. TO RECAP: NO INFECTION, SUSPECTED LOOSE TRILOCK STEM, REPLACED W/ COMPETITOR REVISION STEM, NEW DEPUY POLY LINER AND COMPETITOR FEMORAL HEAD. DOI: (B)(6) 2017. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9167889 ↗