APEXRecalls & reported problems across all models

We found 2 models of APEX by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 637 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and Sep 15, 2026 — classified as 3 deaths, 468 injuries, 166 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported APEX problems

APEX models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• APEX 1246-03-000

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  3 deaths613 reports
• APEX 2346-01-000

  SCREWDRIVER
  24 reports

Recent APEX adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Depuy (Ireland) products

• ATTUNE1,475 models · 41,078 reports · 35 recalls
• QUICKSET66 models · 21,038 reports
• PINNACLE198 models · 7,240 reports
• DELTA XTEND194 models · 5,353 reports
• P.F.C. SIGMA487 models · 5,192 reports · 1 recall
• INHANCE202 models · 4,578 reports
• SMARTSET7 models · 4,415 reports
• SIGMA380 models · 3,831 reports