COMPREHENSIVE SHOULDER SYSTEM 113618Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304554191), received between Dec 7, 2021 and Oct 30, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 FDA recall record name this device's identifier.

6 other recalls cover devices cleared under the same FDA submission (K060692); 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.

Recalls naming this device

1. Jan 7, 2022Terminated

   The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.

   Z-0673-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY APPROXIMATELY 2 WEEKS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INCORRECT ALIGNMENT OF IMPLANTS. THE BASEPLATE WAS LEFT IN, BUT THERE WAS A SIZE EXCHANGE OF THE OTHER COMPONENTS. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029635 ↗
• InjuryDec 7, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SHOULDER REPLACEMENT SURGERY. DURING THE PROCEDURE THE SURGEON ASKED FOR A 18X55 STEM. AFTER VERIFYING ON THE BOX THE CORRECT SIZE, THE STEM WAS HANDED TO THE CIRCULATOR TO OPEN ONTO THE STERILE FIELD. AS THE SURGEON WAS HANDED THE IMPLANT, HE NOTICED THAT IT WAS WAY TOO BIG COMPARED TO WHAT WE NORMALLY IMPLANT. PACKAGE WAS CHECKED AND CONFIRMED EVERYTHING SAID IT WAS SUPPOSED TO BE A 18X55 MICRO STEM BUT INSTEAD THE IMPLANT WAS A 19X122 STEM. KNOWING ANOTHER SET OF MICRO STEMS WERE NOT AVAILABLE, THE SURGEON ELECTED TO USE A MINI STEM WHICH RESULTED IN A FRACTURE OF THE HUMOROUS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 12952279 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060692. One submission often covers many models, so check the product and lot details in each record.

• Z-1543-2020 · Feb 17, 2020 · Terminated
  Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component o
• Z-0591-2019 · Oct 10, 2018 · Terminated
  Comprehensive Mini Stem, Item No. 113631:
• Z-0980-2018 · Dec 8, 2017 · Terminated
  Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
• Z-0979-2018 · Dec 8, 2017 · Terminated
  Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
• Z-0299-2018 · Jun 5, 2017 · Terminated
  COMP PRIMARY STEM 8MM MINI, model # 113628
• Z-1755-2015 · Apr 16, 2015 · Terminated
  Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, hum