APEX 1246-03-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 613 adverse event reports that list this exact device (DI 10603295019688), received between Jul 7, 2017 and Sep 15, 2026 — classified as 3 deaths, 468 injuries, 142 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (129 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 613 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was unstableDOI: (b)(6) 2021.DOR: (b)(6) 2026.Affected side: Unknown.

  Patient problems: Joint Laxity

  MAUDE report 50770830 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Laxity

  MAUDE report 50754583 ↗
• MalfunctionSep 11, 2026Difficult to Insert

  It was reported that the patient underwent an unspecified surgery using the APEX HOLE ELIM POSITIVE STOP product. After the Pinnacle cup was placed, the surgeon attempted to install the product, which locked up midway and could not be fully tightened. The surgery proceeded without use of the product. The surgery was completed successfully without delay. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50731119 ↗
• InjuryJul 28, 2026Noise, Audible

  On (b)(6) 2020, the patient underwent a left total hip replacement in which DePuy Pinnacle components were implanted. Following the procedure, the patient experienced ongoing hip pain, difficulty bearing weight, and mechanical symptoms including catching and locking of the hip.On (b)(6) 2023, the patient underwent a left hip revision surgery due to failure of the implanted components. The patient experienced a popping sensation in the left hip following a previous left total hip arthroplasty. The patient also reported sustaining a fall after slipping two days prior to evaluation. Assessment revealed hip instability with lateral stress, and minimal bone loss was noted following removal of the acetabular cup. During the revision procedure, the surgeon confirmed failure of the DePuy components. The operative findings included a failed titanium-to-titanium acetabular liner, metallosis, and metal wear of the acetabular component. The surgeon observed significant metallosis with darkened tissues and darkened motor-oil-color joint fluid. The gluteus minimus had significant metallosis and degeneration. The capsule had an inner metallosis rind formation. The metallosis issues were debrided

  Patient problems: Bone Notching; Fall; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 50055855 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: ON (B)(6) 2019, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 25374344 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SUSPECTED INFECTION. JOINT WAS WASHED OUT. HEAD AND POLY WERE SWAPPED. APEX HOLE ELIM POSITIVE STOP WAS REMOVED AND NO REPLACEMENT WAS IMPLANTED. DOI: (B)(6) 2019, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25106369 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION ASSOCIATED WITH PROSTALAC. DOI-UNKNOWN. DOR-(B)(6) 2026. AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25086572 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED MORE STABILITY. DOI- (B)(6) 2019. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25073081 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, PATIENT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY DUE TO SEVERE DEGENERATIVE ARTHRITIS. ON (B)(6) 2025, DUE TO ELEVATED IONS AND PERSISTENT PAIN, PATIENT UNDERWENT REVISION, LEFT TOTAL HIP ARTHROPLASTY, RESECTION OF METALLOSIS INCLUDING COMPLETE SYNOVECTOMY, IRRIGATION, AND DEBRIDEMENT. DOI: (B)(6) 2010. DOR: (B)(6) 2025. AFFECTED SITE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 25018074 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, PATIENT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY DUE TO SEVERE DEGENERATIVE ARTHRITIS. ON (B)(6) 2025, DUE TO ELEVATED IONS AND PERSISTENT PAIN, PATIENT UNDERWENT REVISION, LEFT TOTAL HIP ARTHROPLASTY, RESECTION OF METALLOSIS INCLUDING COMPLETE SYNOVECTOMY, IRRIGATION, AND DEBRIDEMENT. DOI: (B)(6) 2010. DOR: (B)(6) 2025. AFFECTED SITE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 25017724 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. CUP APPEARS TO BE VERTICAL AND OVERLY ANTEVERTED. PATIENT ALSO HAS SPINAL/PELVIC ISSUES. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24983839 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REPLACEMENT ON (B)(6) 2023. HIP BECAME PAINFUL. CUP WAS REVISED TO A LARGER SIZE 60 FROM A 58. SURGERY WENT WITHOUT INCIDENT. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 24716555 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS WASHOUT FOR INFECTION. EXPLANTED THE ALTRX 60X36 LINER, THE HOLE ELIMINATOR, AND 36 BIOLOX DELTA HEAD. WASHOUT WAS CONDUCTED AND NEW HOLE ELIMINATOR, 60 ALTRX LINER AND A 36 + 8.5 COBALT CHROME HEAD WAS IMPLANTED. NO DELAY IN SURGERY. NO INJURY TO PATIENT. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 24661618 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS RETURNED TO OR FOR SUSPECTED INFECTION, LINER, HOLE ELIMINATOR AND CERAMIC HEAD WERE EXCHANGED. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24240244 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISED DUE TO PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 24221503 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION IN PATIENT'S HIP. IMPLANTS WERE EXTRACTED AND A TEMPORARY SPACER WAS IMPLANTED TO REMOVE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24041640 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23925971 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23921718 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED LEGAL RECORDS WERE RECEIVED. THERE IS GAS AND SOFT TISSUE SWELLING SURROUNDING THE LEFT PROXIMAL FEMUR COMPATIBLE WITH POSTOPERATIVE CHANGES. LOOSENING OF FEMORAL COMPONENT OF PROSTHETIC LEFT HIP, SYNOVIAL FLUID FROM HIP JOINT, LEFT ARTHRITISM, PROGRESSIVE HIP PAIN AND DISABILITY. 10 ML OF BLACK STAINED FLUID, ACUTE METAL WEAR PROCESS, POLYETHYLENE LINER WAS WORN THROUGH SUPERIORLY AND BROKEN IN THE SUPERIOR RIM. THE CERAMIC BALL WAS NOTED TO HAVE BLACK STAINING ON THE SUPERIOR SURFACE, WEAR OF ARTICULAR BEARING SURFACE OF INTERNAL PROSTHETIC LEFT HIP JOINT, INITIAL ENCOUNTER (CMS/HCC). HAD SEVERE BACK PAIN/MUSCLE SPASMS. COBALT LEVEL OF 77.1 AND A CHROMIUM LEVEL OF 40.1. DURING THE PROCEDURE, APPROXIMATELY 9 ML OF YELLOWISH FLUID WERE REMOVED. MODERATE AMOUNT OF SCAR TISSUE WHICH WAS STAINED BLACK CONSISTENT WITH A METAL STAINING. SCAR TISSUE WAS EXCISED AROUND THE TRUNNION AND THE ACETABULUM CIRCUMFERENTIALLY. LEFT HIP SORENESS, WEAKNESS, AND DECREASED RECALL OF POSTERIOR. FIBROSIS, FOCAL INFARCTION AND HISTIOCYTIC REACTION SPECIMEN SUBMITTED AS SYNOVIAL SCAR TISSUE CONSISTS OF AN IRREGULAR RUBBERY SEGMENT OF TAN GRAY-RED SOFT TISSUE RECEIVED IN FORMALIN MEASURING

  Patient problems: Adhesion(s); Discomfort; Fatigue; Foreign Body Reaction; Pain; Swelling/ Edema

  MAUDE report 23692747 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 23680253 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE (B)(6)), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6) HOSPITAL AND (B)(6), AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. DURING THE REVIEW, DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCTS WERE IDENTIFIED AS INVOLVED IN SOME OF THE COMPLICATIONS. A TOTAL OF 4 COMPLICATIONS INVOLVING JOINT RECONSTRUCTION PRODUCTS HAVE BEEN REPORTED ACROSS 3 PATIENTS. ALL COMPLICATIONS REQUIRED SURGICAL INTERVENTION. SUBJECT NUMBER (B)(4), 70-YEAR-OLD MALE. PATIENT EXPERIENCED A POST OPERATIVE SUPERFICIAL WOUND INFECTION REQUIRING ANTIBIOTICS AND WOUND VAC. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2024.

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 23526157 ↗
• InjuryOct 28, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT A THA SURGERY FOR OA WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY IN (B)(6) 2024, X-RAYS SHOWED NO ABNORMALITIES IN THE LINER IN QUESTION. IN (B)(6) 2025, CT SCAN REVEALED SOME WEAR (ECCENTRICITY OF THE HEAD) MOVEMENT BEHIND THE LINER. ON (B)(6) 2025, THE PATIENT VISITED THE HOSPITAL COMPLAINING OF ABNORMAL NOISE AND PAIN. AN X-RAY REVEALED SIGNIFICANT DISPLACEMENT OF THE FEMORAL HEAD CENTER. DISLOCATION AND WEAR WERE SUSPECTED, BUT THE X-RAY FINDINGS DID NOT REVEAL DISLOCATION. THE SURGEON DOUBTED THAT SUCH EXTENSIVE WEAR COULD OCCUR IN SUCH A SHORT PERIOD OF TIME, AND SUSPECTED LINER DISLOCATION. ON (B)(6), A REVISION WAS SCHEDULED FOR (B)(6) 2025. DURING THE SURGERY, A SALES REPRESENTATIVE CHECKED THE SITUATION FROM THE SURGICAL FIELD AND CONFIRMED THE FOLLOWING: THE LINER AT THE TOP OF THE CUP RIM WAS EMBEDDED INTO THE CUP, WITH THE ANTI-ROTATION TAB DESTROYED. THE DELTA HEAD HAD COLLIDED WITH THE CUP RIM AND THE TAPERED LOCKING PORTION OF THE CUP/LINER (DISCOLORED DUE TO FRICTION WITH THE HEAD), CAUSING SIGNIFICANT DAMAGE. THE SURGEON DETERMINED THAT RE-FIXING THE LINERS WOULD BE DIFFICULT, SO ALL IMPLANTS PLACED I

  Patient problems: Pain

  MAUDE report 23408526 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO INFECTION. STAGE 1 REVISION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23357968 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAINFUL HIP. DO: (B)(6) 2009. DOR: (B)(6) 2025 . AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 23285453 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 23062216 ↗