Comprehensive® Reverse Shoulder XL-115363Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00880304475427), received between Oct 17, 2019 and Dec 31, 2024 — classified as 22 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 reports).

19 other recalls cover devices cleared under the same FDA submission (K080642, K193373); 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2024Unintended Movement; Unintended Movement

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Joint Dislocation

  MAUDE report 21047296 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A KNOWN HISTORY OF NICKEL ALLERGY UNDERWENT A CONVERSION FROM A RIGHT SHOULDER HEMIARTHROPLASTY TO A REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO ROTATOR CUFF DEFICIENCY WITH CAPSULAR CONTRACTURE APPROXIMATELY NINE YEARS (9) AND THREE (3) MONTHS AGO. AFTER IMPLANTATION, THE PATIENT CONTINUED TO HAVE RANGE OF MOTION CONCERNS, PAIN, SWELLING, LOW FEVERS, AND SKIN LESIONS. AFTER A NEGATIVE INFECTION WORKUP, THE PATIENT WAS FOUND TO HAVE AN ALLERGY TO VANADIUM. THE PATIENT UNDERWENT EXPLANTATION OF ALL COMPONENTS APPROXIMATELY FOUR (4) YEARS AND FIVE (5) MONTHS LATER. DURING THE PROCEDURE, THERE WERE NO SIGNS OF LOOSENING OR INFECTION. AN OSTEOTOMY WAS REQUIRED TO REMOVE THE WELL-FIXED STEM. CERCLAGE WIRES WERE PLACED TO STABILIZE THE OSTEOTOMY, BUT NO SHOULDER IMPLANTS WERE INSERTED. NO COMPLICATIONS WERE REPORTED AS A RESULT OF THE SURGERY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fever; Localized Skin Lesion; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19011282 ↗
• InjuryMar 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION DUE TO DISLOCATION OF THE COMPREHENSIVE RSA PROSTHESIS, WHICH WAS FOUND DURING A FOLLOW-UP VISIT, TAKING PLACE APPROXIMATELY 7 DAYS AFTER THE PRIMARY PROCEDURE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 18816092 ↗
• InjuryNov 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY APPROXIMATELY 10 MONTHS AGO. SUBSEQUENTLY, THEY HAD A REVISION APPROXIMATELY 9 MONTHS POST-IMPLANTATION FOR UNKNOWN REASONS. IT WAS STATED THAT THE PATIENT DID NOT FOLLOW THE SURGEON'S INSTRUCTIONS AND THAT THE PATIENT DID NOT HAVE AN INFECTION. THERE WAS NO CONTRIBUTING CONDITION AND THE REVISION WENT ACCORDING TO PLAN. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 18050441 ↗
• InjuryJul 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 17427776 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 17239743 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT IS EXPERIENCING SEVERE TINGLING AND PAIN IN RIGHT SHOULDER THAT INTERFERES WITH DAILY LIVING POST REVISION PROCEDURE. THE PATIENT HAS RECEIVED A SERIES OF SUPRASCAPULAR NERVE BLOCKS AND REFERRED TO PHYSIO, OUTCOME STILL PENDING. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain; Peripheral Nervous Injury

  MAUDE report 16630098 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A CONVERSION FROM A HEMIARTHROPLASTY TO A REVERSE SHOULDER ARTHROPLASTY APPROXIMATELY THREE (3) YEARS AND EIGHT (8) MONTHS AGO. SUBSEQUENTLY, ONE (1) YEAR AND SEVEN (7) MONTHS LATER, PATIENT REPORTS UNUSUAL PAIN FOLLOWING A FALL ONTO OUTSTRETCHED HANDS. THE PATIENT UNDERWENT A COURSE OF PHYSICAL THERAPY AND TAKES OTC MEDICATIONS AS NEEDED FOR PAIN. APPROXIMATELY TWO (2) MONTHS AGO, RADIOGRAPHIC IMAGING DISPLAYED STRESS SHIELDING IN LATERAL CORTEX AND THE PATIENT IS EXPERIENCING SOME DIFFICULTY PERFORMING DAILY ACTIVITIES. NO PLAN FOR REVISION HAS BEEN REPORTED AND THE PATIENT HAS REMAINED EXTREMELY SATISFIED THROUGHOUT THE STUDY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Erosion; Fall; Pain

  MAUDE report 16382466 ↗
• InjuryNov 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY APPROXIMATELY THREE (3) YEARS AND SIX (6) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY FOR AN UNKNOWN REASON ONE (1) MONTH LATER.

  Patient problems: Insufficient Information

  MAUDE report 15762280 ↗
• InjuryAug 11, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING SHOULDER PAIN, INSTABILITY, AND ROM ISSUES APPROXIMATELY SEVEN YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 15212197 ↗
• InjuryJul 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT HAD A REVISION DUE TO DISLOCATION OF HIS COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY FROM HIS SURGERY APPROXIMATELY 2 MONTHS EARLIER. PATIENT WAS ASYMPTOMATIC BUT DISLOCATION WAS PICKED UP ON AN X-RAY REQUESTED FOR 6 WEEK FOLLOW UP. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 15107805 ↗
• InjuryJun 7, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SHOULDER DISLOCATION WHICH CAUSED A LARGE HEMATOMA IN THE JOINT. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO THE SAME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Hematoma; Joint Dislocation

  MAUDE report 14620505 ↗
• InjuryMar 1, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, IN AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING WITH PERIPROSTHETIC OSTEOLYSIS, WEAR OF THE POLY COMPONENT, AND METALLOSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 13633482 ↗
• InjuryOct 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 12590083 ↗
• InjuryJul 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 12100635 ↗
• MalfunctionApr 29, 2021Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744733 ↗
• MalfunctionApr 5, 2021Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614802 ↗
• InjuryApr 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE RECEIVED ADDITIONAL INFORMATION DOES NOT CHANGE THE FINAL CONCLUSIONS OF PREVIOUS INVESTIGATION.

  Patient problems: Joint Dislocation

  MAUDE report 11602514 ↗
• InjuryMar 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 11555282 ↗
• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. HOWEVER, TESTS FOR INFECTION WERE NEGATIVE. PATIENT STILL PRESENTED WITH PAIN OF UNKNOWN CAUSE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11365337 ↗
• InjuryFeb 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION IS AVAILABLE FOR THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 11321740 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 11292713 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Limited Mobility Of The Implanted Joint; Numbness; Tingling; Tissue Damage

  MAUDE report 10682947 ↗
• InjuryFeb 19, 2020Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT HAS BEEN REPORTED PATIENT UNDERWENT RIGHT REVERSE SHOULDER ARTHROPLASTY 9 YEARS AGO. SUBSEQUENTLY PATIENT IS INDICATED TO BE REVISED DUE TO DISLOCATION, LOOSENING, AND MIGRATION, BUT SURGERY HAS YET TO BE SCHEDULED.

  Patient problems: Joint Dislocation; Osteolysis; Osteopenia/ Osteoporosis

  MAUDE report 9727099 ↗
• MalfunctionDec 31, 2019Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9534939 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080642, K193373. One submission often covers many models, so check the product and lot details in each record.

• Z-0619-2021 · Nov 25, 2020 · Terminated
  Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 1805
• Z-0093-2021 · Sep 2, 2020 · Terminated
  Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for t
• Z-2144-2020 · Apr 17, 2020 · Terminated
  Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comp
• Z-1750-2020 · Mar 13, 2020 · Terminated
  Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the gle
• Z-1859-2017 · Feb 17, 2017 · Terminated
  various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Sh
• Z-1103-2017 · Dec 20, 2016 · Terminated
  Comprehensive Reverse Shoulder System Humeral Tray Model 115340
• Z-1548-2013 · May 15, 2013 · Terminated
  Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
• Z-2543-2011 · Apr 22, 2011 · Terminated
  Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile, single use, REF 115348, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Should
• Z-2544-2011 · Apr 22, 2011 · Terminated
  Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, single use, REF 115345, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulde
• Z-2542-2011 · Apr 22, 2011 · Terminated
  Bio-modular reverse shoulder humeral tray with lock ring, 44 mm standard, sterile, single use, REF 11-113680, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder
• Z-2546-2011 · Apr 22, 2011 · Terminated
  Custom bi-angular to reverse shoulder humeral tray 44 mm sterile, REF CP561548, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated fo
• Z-2547-2011 · Apr 22, 2011 · Terminated
  Custom solar comprehensive reverse humeral tray with lock ring 44 mm +5mm, sterile, REF CP561659, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder product
• Z-2549-2011 · Apr 22, 2011 · Terminated
  Custom comprehensive reverse humeral tray set w/ lock rings 44 mm + 15 mm & + 18 mm sterile, REF CP561705, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder
• Z-2548-2011 · Apr 22, 2011 · Terminated
  Custom biomodular humeral tray 44 mm sterile, REF CP561686, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients who
• Z-2541-2011 · Apr 22, 2011 · Terminated
  Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, single use, REF 11-113685, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse S

…and 4 more.