DELTA XTEND 130720101Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295027287), received between Jul 25, 2017 and Jul 9, 2025 — classified as 24 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K071379, K120174, K192448, K192855); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF DELTA XTEND DUE TO INFECTION. DOI: UNKNOWN 2015, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22462432 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY DONE (B)(6) 2016 AT THE HOSPITAL BY THE SURGEON. THE PATIENT'S SHOULDER WAS INFECTED, AND THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM SINGLE STAGE WASHOUT. EPI, POLY, AND GLENOSPHERE WERE REMOVED. THE SHOULDER WAS WASHED OUT AND NEW COMPONENTS WERE IMPLANTED. STABILITY WAS CONFIRMED AND NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19449367 ↗
• InjuryJul 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INITIAL SURGERY ON (B)(6) CONVERTED A UNITE ANATOMIC TSA TO A REVERSE TSA. THE PATIENT BECAME UNSTABLE AND DISLOCATED IN LAST FEW WEEKS. DURING REVISION IT WAS DISCOVERED THE EPI WAS NOT COMPLETELY LOCKED DOWN AND HAD ROTATED. SURGEON REMOVED ALL DEPUY COMPONENTS AND WENT BACK WITH ARTHREX WHICH HE USES REGULARLY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 17343800 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RIGHT-SIDED REVERSE TOTAL SHOULDER I&D WAS PERFORMED FOR UNKNOWN REASON. DOI: (B)(6) 2014, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 16466485 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE, THE PRIMARY RSA WAS PERFORMED WITH DELTA XTEND SYSTEM. ON AN UNKNOWN DATE, IT WAS FOUND THAT THE PATIENT HAD POSTOPERATIVELY BECOME INFECTED. ON AN UNKNOWN DATE, THEY REMOVED THE DEVICES IN QUESTION, CLEANSED THE LESION AND COMPLETED DEVICE REPLACEMENTS.

  Patient problems: Unspecified Infection

  MAUDE report 12908245 ↗
• MalfunctionNov 21, 2021Difficult to Insert; Difficult to Insert

  DURING THE PROCEDURE, THE SURGEON NOTICED THAT MATING THE EPIPHYSIS TO THE STEM SEEMED MORE DIFFICULT THAN USUAL AND TRIED TWO DIFFERENT COMBINATIONS. HE SUCCESSFULLY IMPACTED ONE EPIPHYSIS TO A STEM AND ENGAGED THE ATTACHING SCREW SUCCESSFULLY IMPLANTING BOTH PIECES AND COMPLETING THE SURGERY. NO ADVERSE EVENTS OCCURRED BESIDE A 3-5 MINUTE DELAY WHEN RETRIEVING THE OTHER IMPLANTS AND THE SURGEON MANUALLY SOLVING THE ISSUE. DOE: (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12850059 ↗
• MalfunctionAug 24, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT TWO IMPLANTS WERE OPENED AND WERE FOUND TO HAVE A DEFECTIVE PROBLEM WITH PUTTING THEM TOGETHER. THE EPI STEM WOULD NOT FIT INTO THE OPENING ON THE UNITE STEM. MINIMAL SURGICAL TIME WAS WASTED AND THE PROBLEM IMPLANTS WERE NEVER INTRODUCED TO THE PATIENT. THERE WAS NO IMPLANT/EXPLANT AS THE PROBLEM WAS DETECTED EARLY AND ALL PARTS WERE RETRIEVED FOR RETURN.

  Patient problems: Insufficient Information

  MAUDE report 12358430 ↗
• MalfunctionAug 16, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SIZE 1 CENTER EPI DID NOT FIT INTO THE UNITE STEM. NO DELAYS AS A SECOND IMPLANT WAS OPENED AND FIT PERFECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12327995 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS CONJOINT TENDON IMPINGEMENT. DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (LEFT SHOULDER).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12316374 ↗
• MalfunctionAug 11, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PART DID NOT FULLY SEAT INTO THE GLOBAL UNITE STEM. NO PROBLEMS WITH THE STEM AND NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309296 ↗
• MalfunctionJul 2, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN ATTEMPTING TO CONNECT THE SIZE 1 EPI TO THE GLOBAL UNITE SIZE 10 STEM, THE TWO IMPLANTS WOULD NOT CONNECT DUE TO A MISMATCH OF THE STEM AND HOLE USED TO CONNECT THE 2 IMPLANTS. THE IMPLANTS WERE THEN REMOVED FROM THE FIELD AND TWO NEW IMPLANTS WERE PRESENTED TO THE FIELD. THERE WAS NO DELAY IN SURGERY AND THE IMPLANTS ON THIS REPORT WERE NEVER IMPLANTED IN THE PATIENT. DOE: (B)(6) 2021, UNKNOWN AFFECTED SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108374 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HUMERAL FRACTURE DUE TO FALL AND LOOSENING OF THE HUMERAL STEM AT THE BONE TO IMPLANT INTERFACE. THE PATIENT HAD A DELTA EXTEND REVERSE SHOULDER IMPLANTED YEARS AGO. THE HUMERAL COMPONENTS WERE REVISED AND THE METAGLENE, SCREWS AND GLENOSPHERE WERE LEFT IMPLANTED. AN 8MM UNITE REVISION STEM, SIZE 1 CENTERED EPI, 2 SPACERS AND A 42MM + 3 POLY WERE IMPLANTED. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT SHOULDER.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 11118102 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION OF SPINAL HARDWARE/SHOULDER IMPLANTS. SURGEON REMOVED ALL SHOULDER IMPLANTS AND OUT IN AN ANTIBIOTIC SPACER. UPON OPENING THE JOINT HE FOUND TRACES OF METALOASIS, SURGEON WAS UNSURE WHAT CAUSED IT. THE GLENOSPHERE WAS LOOSE AND PULLED OUT WITH A RONGUER. THE METAGLENE BASEPLATE AND SCREWS ALL CAME OUT WITH THE GLENOSPHERE. THE INFERIOR LOCKING SCREW WAS BROKEN MIDWAY ON THE SCREW. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2017, DOR: (B)(6) 2020, RIGHT SHOULDER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction

  MAUDE report 11117458 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH A RIGHT SHOULDER PROSTHETICS ON THE (B)(6) 2020 DUE TO AN UNKNOWN REASON. DURING RECOVERY THE PATIENT RECEIVED A CLOSED REDUCTION TO TREAT A PAIN AND INSTABILITY SECONDARY TO A DISLOCATION CAUSED BY A FALL. THE RECOVERY COURSE HAS BEEN COMPLICATED BY A COVID INFECTION. THE PATIENT WILL BE REVISED IN (B)(6) 2021 AFTER A NICKEL FREE IMPLANT IS RECEIVED DUE TO THE PATIENT'S NICKEL ALLERGY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Fall; Joint Laxity; Loss of Range of Motion; Pain; Pneumonia

  MAUDE report 11056827 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S SHOULDER WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND AN ABX SPACER WAS IMPLANTED. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, UNKNOWN SHOULDER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10935678 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS AN RTSA (REVERSE TOTAL SHOULDER ARTHROPLASTY) TREATING CUFF TEAR ARTHROPLASTY ON (B)(6) 2020. WHEN THE MODULAR CENTERED EPIPHYSIS WAS INSERTED INTO THE HUMERUS, THE INNER CORTICAL BONE CRACKED. THE SURGEON CORRECTED THE STEM AND REINSERTED THE IMPLANT, BUT THE GREATER TUBERCLE CRACKED. HE LEFT THE IMPLANT DEPLOYED IN THE HUMERUS, TIED UP THE CRACKED BONES, AND COMPLETED THE PROCEDURE LESS THAN 30-MINUTE SURGICAL DELAY. THE PATIENT IS CURRENTLY HOSPITALIZED, AND SHE IS NOT SCHEDULED TO UNDERGO A REVISION PROCEDURE. THE SURGEON COMMENTED AS FOLLOWS: HE PERFORMED THE PROCEDURE AS PER SURGICAL INSTRUCTION. HE EVALUATED THIS EVENT AS SEVERE. HE USUALLY USES OTHER SUPPLIERS¿ DEVICES BUT HAS NOT EXPERIENCED SUCH A CASE BEFORE. THE BONE SIZE AND FRAGILITY MIGHT HAVE TRIGGERED THE EVENT. THE PATIENT¿S MEDICAL HISTORY, TREATMENT HISTORY, AND COMORBIDITY HAD NOTHING NOTICEABLE. SHE DOES NOT HAVE AN ALLERGY OR SMOKE. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10885326 ↗
• InjurySep 16, 2020Loss of Osseointegration; Loss of Osseointegration

  REASON FOR REVISION: ASEPTIC LOOSENING LEADING TO DISLOCATION, PAIN & OSTEOLYSIS. THE REASON FOR REVISION IS DISLOCATION. THE CAUSE OF THE DISLOCATION IS UNCERTAIN. SHE IS DEMENTED, AND THERE IS AN X-RAY DOCUMENTING A REDUCED JOINT THREE WEEKS AGO. THE JOINT HAS BEEN PAINFUL. HUMERAL COMPONENT MAY BE LOOSE. PATIENT WILL BE REVISED TO A CEMENTED HUMERAL COMPONENT, THOUGH STABILITY MAY STILL BE AN ISSUE. ATTENDED REVISION CASE. PRIMARY PE CUP AND HUMERAL STEM WERE WORN AND EXPLANTED. SURGEON NOTED 'TARNISHING" TO THE GLENOSPHERE, BUT OPTED TO LEAVE IT IN-SITU DUE TO PATIENT FRAILTY DESPITE ADVICE TO EXCHANGE IT. CEMENTED DELTA XTEND (LONG STEM) USED WITH NEW PE CUP DURING REVISION TO RESTORE FUNCTION. SURGEON BELIEVES THAT OSEO-INTEGRATION OF THE PRIMARY HUMERAL STEM NEVER FULL OCCURED SO STEM BECAME LOOSE AND MAL-ROTATED CAUSING IMPLANT IMPINGEMENT & METAL ON METAL CONTACT/WEAR LEADING TO FURTHER ASEPTIC LOOSENING AND SUBSEQUENT OSTEOLYSIS AND DISLOCATION. ACTION TAKEN :THE PATIENT REQUIRED A REVISION TO A CEMENTED DELTA XTEND LONG STEM WITH NEW PE CUP. PATIENT CONDITION: DEMENTIA. FEMALE PATIENT INITIALS: M.M HEIGHT 180CM WEIGHT (B)(6).

  Patient problems: Inadequate Osseointegration; Joint Disorder; No Code Available; Pain

  MAUDE report 10541693 ↗
• InjuryJun 11, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD PRIMARY REVERSE SHOULDER ARTHROPLASTY ON THE (B)(6) 2015. APPROXIMATELY THREE MONTHS AGO THE PATIENT STARTED EXPERIENCING PAIN IN THE OPERATIVE SHOULDER. HE APPROACHED THE TREATING SURGEON AND SURGEON CONFIRMED ASEPTIC LOOSENING OF THE HUMERAL COMPONENT. REVISION SURGERY PERFORMED ON TUESDAY THE (B)(6) 2020 AT (B)(6) HOSPITAL. CONFIRMED DURING SURGERY THAT HUMERAL COMPONENT WAS LOOSE AS IT COULD BE REMOVED WITHOUT THE AID OF INSTRUMENTS.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10145387 ↗
• InjuryMar 25, 2020Loss of Osseointegration; Loss of Osseointegration

  STEM LOOSENING.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9880058 ↗
• InjuryMar 10, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE HUMERAL STEM AT THE BONE TO IMPLANT INTERFACE. THE REFERENCE NUMBER RECORDED FROM THE STEM ISN¿T REGISTERING WITH THE SYSTEM, BUT IT IS THOUGHT TO BE A SIZE 10 STANDARD GLOBAL UNITE STEM. IMPLANT INFORMATION IS AVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9813624 ↗
• MalfunctionFeb 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2014: PATIENT UNDERWENT A RIGHT RTSA WITH A DEPUY IMPLANT, GLOBAL UNITE AND DELTA XTEND SECONDARY TO A HUMERUS FRACTURE. PATIENT ALSO HAD OPEN REDUCTION BONE GRAFTING AND CLEANING OUT OF SYNOVIAL PSEUDARTHROSIS PERFORMED. NO INTRAOPERATIVE COMPLICATIONS. CEMENT MANUFACTURER NOT SPECIFIED. ON (B)(6) 2015: THE PATIENT WAS SEEN FOR THE FIRST TIME POSTOPERATIVELY. THE SURGEON¿S NOTES REVEAL THAT IS DUE TO THE PATIENT HAVING A PORT PLACED FOR DIALYSIS AND SOME MENTAL STATUS CHANGES. UPON PHYSICAL EXAMINATION, THE HUMERAL SHAFT NONUNION IS COMPLETELY HEALED, HOWEVER, THE RIGHT HUMERUS IS DETERMINED TO BE DISLOCATED MEDIALLY; IT DOES NOT MOVE AT ALL, THE PATIENT DOES NOT REPORT PAIN AND HE IS ABLE TO FUNCTION WITHIN FUNCTIONAL LIMITS. NO TREATMENT INDICATED AND FOLLOW-UP AGAIN IN THREE MONTHS. PMH: ROTATOR CUFF TEAR, SYNOVIAL PSEUDARTHROSIS, CORONARY BYPASS GRAFTING. DOI: (B)(6) 2014 (RTSA). DOE: (B)(6) 2015 (FOLLOW-UP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9732241 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2019. RIGHT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8815969 ↗
• InjuryMay 2, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE HUMERAL STEM AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. LOOSE SHOULDER PROSTHESIS. NO ADDITIONAL INFORMATION. DOI: UNKNOWN, DOR: (B)(6) 2019. LEFT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 8573480 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF ALL SHOULDER ARTHROPLASTY COMPONENTS; CONTINUED HISTORY OF PAIN AND STIFF SHOULDER SINCE SURGERY. ALL COMPONENTS REMOVED, DISCARDED, AND TEMPORARY PROSTHESIS (GLOBAL AP WITH CTA HEAD) IMPLANTED WITH ANTIBIOTIC CEMENT.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 8573275 ↗
• MalfunctionApr 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ETCH MARK IN THE EPI 1 DID NOT LINE UP WITH THE 0 MARK WHEN ASSEMBLING THE STEM AND EPI. 1 MINUTE SURGICAL DELAY. DOE: (B)(6) 2019, RIGHT SHOULDER.

  Patient problems: Not Applicable

  MAUDE report 8490958 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071379, K120174, K192448, K192855. One submission often covers many models, so check the product and lot details in each record.

• Z-0834-2018 · Aug 31, 2017 · Terminated
  DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with n
• Z-0833-2018 · Aug 31, 2017 · Terminated
  DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients wi