AEQUALIS RESURFACING HEADRecalls & reported problems across all models

We found 8 models of AEQUALIS RESURFACING HEAD by Tornier in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2016 and Sep 9, 2024 — classified as 19 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 AEQUALIS RESURFACING HEAD problems

AEQUALIS RESURFACING HEAD models

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

• AEQUALIS RESURFACING HEAD DWD804

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  9 reports
• AEQUALIS RESURFACING HEAD DWD806

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  4 reports
• AEQUALIS RESURFACING HEAD DWD805

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• AEQUALIS RESURFACING HEAD DWD803

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  2 reports
• AEQUALIS RESURFACING HEAD DWD802

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS RESURFACING HEAD DWD808

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  1 report
• AEQUALIS RESURFACING HEAD DWD809

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  1 report
• Aequalis Resurfacing Head MWB072

  IMPACTOR
  1 report

Recent AEQUALIS RESURFACING HEAD adverse event reports

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

• MalfunctionSep 9, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PLASTIC PART OF THE IMPACTOR WAS FOUND LOOSE OR BROKEN DURING THE SET INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176281 ↗
• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A POST-OPERATIVE COMPLICATION DESCRIBED AS SUB ACROMIAL IMPINGEMENT DUE TO ACROMIAL SPUR. "PATIENT COMPLAINING OF SEVERE PAIN WITH MOVEMENT. CT ARTHROGRAM REVEALED AN ACROMIAL OSTEOPHYTE CAUSING IMPINGEMENT." THE PATIENT UNDERWENT A SECOND RE-OPERATION WITHOUT COMPONENT CHANGE: ARTHROSCOPIC PROCEDURE CONSISTING OF AN EXTENSIVE DEBRIDEMENT, ADHESIOLYSIS, PANCAPSULAR RELEASE, SUB ACROMIAL DECOMPRESSION, AND SUB CORACOID OSTEOPHYTE REMOVAL.

  Patient problems: Bacterial Infection; Implant Pain

  MAUDE report 14119389 ↗
• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POST-OPERATIVE COMPLICATION. THE PATIENT HAD TO UNDERGO RE-OPERATION WITHOUT COMPONENT CHANGE: ARTHROSCOPIC DEBRIDEMENT, ADHESIOLYSIS BIOPSIES FOR CULTURES AND SUB ACROMIAL DECOMPRESSION, SHOWING 2 POSITIVE BACTERIAL CULTURES (1 FOR C ACNES AND 1 FOR GRAM POSITIVE RODS). PATIENT HAS BEEN TREATED WITH ANTIBIOTICS. THE ADVERSE EVENT IS STILL ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Adhesion(s); Bacterial Infection

  MAUDE report 14119388 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A POST-OPERATIVE COMPLICATION DESCRIBED AS SUBACROMIAL IMPINGEMENT DUE TO ACROMIAL SPUR."PATIENT COMPLAINING OF SEVERE PAIN WITH MOVEMENT. CT ARTHROGRAM REVEALED AN ACROMIAL OSTEOPHYTE CAUSING IMPINGEMENT."

  Patient problems: Adhesion(s); Implant Pain

  MAUDE report 14115928 ↗
• MalfunctionFeb 25, 2022Off-Label Use; Off-Label Use

  IMPLANT WAS EXPIRED. SURGEON DECIDED TO IMPLANT EXPIRED IMPLANT. NO BACKGUP IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13606727 ↗
• InjuryFeb 12, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "IT WAS REPORTED THAT A PATIENT HAD A HUMERAL COMPONENT LOOSENING 13 YEARS AFTER PRIMARY SURGERY, THE REVISION IS SCHEDULED ON (B)(6) 2020, PATIENT ID: (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9698953 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR PAIN 17 MONTHS AFTER PRIMARY SURGERY. PATIENT ID: (B)(6).

  Patient problems: Pain

  MAUDE report 9241730 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ADVERSE EVENT DESCRIBED AS "SUBLUXATION/DISLOCATION OF THE STUDY SHOULDER RELATED TO SEIZURE" 2 YEARS AFTER PRIMARY SURGERY. PATIENT ID: (B)(6).

  Patient problems: Joint Dislocation

  MAUDE report 9241728 ↗
• MalfunctionDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO GLENOID WEAR, 4 YEARS POST-OPERATIVE. SUBJECT ID : (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8133632 ↗
• InjurySep 18, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "GROSS LOOSENING OF GLENOID WITH MIGRATION INTO AXILLARY RECESS. LOOSENING OF HUMERAL HEAD COMPONENT WITH NOTCHING OF THE MEDIAL PROXIMAL HUMERUS JUST BELOW THE IMPLANT. (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7884672 ↗
• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR GLENOID EROSION AT 14 YEARS POST-OPERATIVE. PATIENT (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7618730 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR LOOSENING/LYSIS AT 8 YEARS POST-OPERATIVE. (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7560079 ↗
• InjuryFeb 16, 2018Material Erosion; Material Erosion

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO WEAR-GLENOID, 6 YEARS POST-OPERATIVE. PATIENT ID : (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7276396 ↗
• InjuryMay 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AT 7.5 YEARS POST-OPERATIVE DUE TO GLENOID EROSION. CONVERSION TO RSA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6568420 ↗
• InjuryJan 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AT 2 YEARS POST-OP DUE TO PROGRESSION OF DISEASE. CONVERSION HEMI TO TSA. PATIENT (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6272789 ↗

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