DELTA CTA 4CHL636Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295170471), received between Nov 10, 2017 and Nov 26, 2019 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION PROCEDURE WAS CARRIED OUT AS A RESULT OF THE PATIENT FALLING RESULTING IN THE LOOSENING OF THE GLENOID COMPONENTS. ALSO NOTED ON THE X-RAYS WERE SUBSTANTIAL SCAPULAR NOTCHING AND BROKEN SCREWS. HUMERAL STEM AND EPIPHYSIS REMAINED IN SITU, HUMERAL LENGTHENER AND HUMERAL HEAD ADDED TO THE EXISTING CONSTRUCT.

  Patient problems: Injury; No Code Available

  MAUDE report 9376418 ↗
• InjuryJun 7, 2019Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO NOTCHING. DOI: (B)(6) 2008; DOR: (B)(6) 2019, LEFT SHOULDER.

  Patient problems: Injury; No Code Available

  MAUDE report 8678306 ↗
• InjuryMay 2, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD A FALL IN 2016. SINCE THE FALL, SHE HAS BEEN UNSTABLE AND THERE WAS A REDUCTION IN RANGE OF MOTION. THE POSTERIOR RIM OF THE EPIPHYSIS INSERT WAS FRACTURED OFF. REPLACED WITH NEW INSERT. DOI: (B)(6) 2006, DOR: (B)(6) 2019, RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; No Code Available

  MAUDE report 8573898 ↗
• InjuryJun 8, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2005 FOR A GLENOHUMERAL ARTHROSIS. THEN THE PATIENT HAS BEEN HOSPITALIZED ON THE (B)(6) 2018 WITH A SEPTIC SHOCK . ON THE (B)(6) 2018 A REMOVAL SURGERY WAS PERFORMED. THE STEM APPEARED TO BE DISLOCATED AND WITH BIOFILM INSIDE OF THE MEDULLARY CANAL. THE GLENOSPHERE APPEARED TO BE DISLOCATED AS WELL AND IT PRESENTED INFECTED MATERIAL ORGANIZED AS A BIOFILM.

  Patient problems: Joint Dislocation; Not Applicable; Septic Shock; Unspecified Infection

  MAUDE report 7583453 ↗
• InjuryApr 9, 2018Fitting Problem; Fitting Problem

  DER STATES THAT THE NEW 9MM CTA HUMERAL SPACER WOULD NOT SCREW INTO THE IMPLANTED CEMENTED MONO BLOCK STEM SO THE SURGEON CHOOSE TO CUT THE THREADS OFF THE IMPLANT AND ONLY USE THE TAPER AS A LOCKING MECHANISM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Not Applicable

  MAUDE report 7406626 ↗
• InjuryApr 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. THE SURGEON DID A REVERSE CTA LEFT SHOULDER FOR THIS PATIENT AROUND 2007. TODAY THE SURGEON OPERATED ON PATIENT TO REVISE THE POLY CUP. INTRA-OPERATIVELY THE POLY WAS FOUND TO BE WORN SEVERELY. THE SURGEON SAID THE IMPLANTS WERE WELL FIXED AND DECIDED TO ADD A 9MM SPACER AND A 36+6 RETENTIVE CUP. THIS TRIAL CONSTRUCT APPEARED TO BE STABLE INTRA-OPERATIVELY. DOI: 2007; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7395850 ↗
• InjuryNov 10, 2017Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AT RIGHT REVERSE TOTAL SHOULDER AND POLY WEAR WITH SOFT TISSUE IMBALANCE. ORIGINAL SURGERY APPROX 15 YEARS AGO.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 7022754 ↗