SUMMITRecalls & reported problems across all models

We found 53 models of SUMMIT by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 697 adverse event reports in the FDA's MAUDE database, received between Nov 4, 2014 and Sep 16, 2026 — classified as 1 death, 653 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (74 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 SUMMIT problems

SUMMIT models

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

• SUMMIT 1570-12-110

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  53 reports
• SUMMIT 1570-12-120

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  51 reports
• SUMMIT 1570-12-135

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  48 reports
• SUMMIT 1570-02-110

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  46 reports
• SUMMIT 1570-12-100

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  44 reports
• SUMMIT 1570-02-120

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  1 death37 reports
• SUMMIT 1570-02-100

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  36 reports
• SUMMIT 1570-05-100

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  22 reports
• SUMMIT 1570-02-090

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  21 reports
• SUMMIT 1570-02-135

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  19 reports
• SUMMIT 1570-03-100

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  16 reports
• SUMMIT 1570-12-150

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  16 reports
• SUMMIT 1570-03-080

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  15 reports
• SUMMIT 1570-06-100

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  15 reports
• SUMMIT 1570-13-120

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  15 reports
• SUMMIT 2570-05-125

  DRIVER, PROSTHESIS
  15 reports
• SUMMIT 1570-05-090

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  14 reports
• SUMMIT 1570-12-090

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  14 reports
• SUMMIT 1570-02-150

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  13 reports
• SUMMIT 1570-03-110

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  13 reports
• SUMMIT 1570-05-110

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  13 reports
• SUMMIT 1570-13-100

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  11 reports
• SUMMIT 1570-06-080

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  10 reports
• SUMMIT 1570-12-080

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  10 reports
• SUMMIT 1570-03-090

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  9 reports
• SUMMIT 1570-03-120

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  9 reports
• SUMMIT 1570-05-120

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  9 reports
• SUMMIT 1570-06-090

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  9 reports
• SUMMIT 1570-13-090

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  9 reports
• SUMMIT 1570-05-135

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  8 reports
• SUMMIT 1570-13-110

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  8 reports
• SUMMIT 1570-02-165

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  6 reports
• SUMMIT 1570-03-135

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  6 reports
• SUMMIT 1570-06-110

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  6 reports
• SUMMIT 1570-06-120

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  6 reports
• SUMMIT 1570-12-165

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  6 reports
• SUMMIT 1570-13-150

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  6 reports
• SUMMIT 1570-02-080

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  5 reports
• SUMMIT 1570-13-135

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  4 reports
• SUMMIT 1570-02-070

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  3 reports
• SUMMIT 1570-06-135

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  3 reports
• SUMMIT 1570-05-080

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• SUMMIT 1570-05-150

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  2 reports
• SUMMIT 1570-12-070

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  2 reports
• SUMMIT 1570-12-180

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  2 reports
• SUMMIT 2570-13-250

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  2 reports
• SUMMIT 2570-13-300

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  2 reports
• SUMMIT 1570-06-150

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 report
• SUMMIT 1570-24-017

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 report
• SUMMIT 2570-10-500

  TRAY, SURGICAL, INSTRUMENT
  1 report
• SUMMIT 2570-13-050

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• SUMMIT 2570-13-400

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• SUMMIT 2570-13-450

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent SUMMIT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presents with pain in her thigh post THA on the above listed date. There appears to be significant lysis around the femoral stem. This patient does not walk as she only transfers from a bed to a wheelchair. Stem is easily removed as the cement was only adhered to the stem proximally. Cement distal to the lytic activity was well fixed and left in place. Massive bone loss was noted both laterally and anteriorly. The liner was exchanged and a new stem and head were cemented with no delay nor patient harm. Cement pressurization was quite difficult with the missing bone but the new implants appeared to be well fixed and ROM was deemed appropriate by the surgeon. Distal centralizer was unable to be removed. It was reported that patient was revised due to femoral stem loosening at unknown interface. Cement manufacturer was unknown.DOI: on (b)(6) 2021,DOR: on (b)(6) 2026,Affected side: Left Hip.

  Patient problems: Bone Notching; Osteolysis; Pain

  MAUDE report 50790737 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient fell and broke lateral side of the bone. Surgeon removed the Summit stem and implanted a revision stem. Surgeon swapped out the liner and head also.DOI: (b)(6) 2013.DOR: (b)(6) 2026.Affected Side: Left Hip.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 50733399 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50155373 ↗
• MalfunctionJul 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK TRIAL WOULD NOT SLIDE ONTO THE BROACH. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738273 ↗
• InjuryJul 7, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT DISLOCATED A BIPOLAR AND REVISED TO AN EMPHASIS DUAL MOBILITY. WHEN TRYING TO TAKE THE BIPOLAR HEAD OFF THE STEM, THE STEM WAS DISLODGED. THERE WAS NO FAILURE ON THIS PART OF THE IMPLANT. IT WAS NOTED THE CEMENT USED WAS NOT DEPUYSYNTHES CEMENT. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 25735769 ↗
• MalfunctionMay 12, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT INSTRUMENT HAD UNKNOWN ALLEGATION IT DID NOT HAPPEN IN SURGERY. INVESTIGATION DETERMINED THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149714 ↗
• MalfunctionApr 21, 2026Peeled/Delaminated

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LID HAS A BIG CRACK RUNNING THROUGH THE MIDDLE AND TRAY ITSELF HAS BLACK COATING COMING OFF THE INSTRUMENT PLACE HOLDERS. IT WAS REPORTED THAT THERE WERE NO DELAYS AND NOTHING WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24943680 ↗
• InjuryMar 30, 2026Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STEM WAS LOOSE. THE REP DO NOT HAVE ANY INFO ON WHAT CEMENT WAS USED BUT STEM CAME OUT WITH STEM FULLY COATED IN CEMENT EXCEPT THE TIP. LOOSENING INTERFACE: UNKNOWN . AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728507 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SUMMIT DUOFIX TAP SZ7 HI OFF, DEPUY ASR XL FEM IMP SIZE 53, ASR ACETABULAR IMPLANT 60, AND TAPER SLEEVE ADAPTER 12/14 +8 WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED INFECTION OF ASR HIP IMPLANTS, WITH THE PATIENT REQUIRING HOSPITALIZATION AND TREATMENT UNDER INFECTION PROTOCOLS. ALL IMPLANTS WERE KEPT IN SITU AS NO REPLACEMENT PRODUCTS WERE AVAILABLE, AND NO REVISION SURGERY WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 24039119 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMORAL STEM AND HEAD WERE REVISED DUE TO FEMORAL FRACTURE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 23993079 ↗
• InjuryDec 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STEM WAS LOOSE AND CAME OUT AFTER REMOVING THE HEAD. IT WAS STATED THAT THE STEM WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS CEMENT TO IMPLANT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23864747 ↗
• InjuryDec 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 FOR FALL AND FRACTURE. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Limb Fracture

  MAUDE report 23817634 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BIPOLAR REMOVED BECAUSE OF INFECTION. AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23716154 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23544301 ↗
• MalfunctionOct 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AIMING ARM/INSERTION HANDLE FOR TN-ADVANCED CAUSED SCREWS TO MISS THE NAIL. ISSUE WAS WITH TNA SUPRA-PATELLAR NAIL AIMING ARM AND INSERTION HANDLE ARE THE ISSUE. STILL EXPERIENCING PROBLEMS WITH THE PROXIMAL LOCKING HOLES BEING MISSED WHEN DRILLING THE MEDIAL-TO-LATERAL PROXIMAL LOCKING SCREWS. THE DRILL BIT IS CONSISTENTLY STRIKING THE NAIL, CAUSING VIBRATION THROUGHOUT THE CONSTRUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397976 ↗

Other Depuy Orthopaedics, Inc. products

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