MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X20 ST; SHOULDER PROSTHESIS SCREW

Catalog Number 180551

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abdominal Pain (1685)

Event Date 05/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Common device name: phx.Concomitant medical devices: comp primary stem 7mm mini cat# 113627 lot# 534700; comp rvrs shldr glnsp std 36mm cat# 115310 lot# 403190; comp aug mini bsplt w tpr sm cat# 110032410 lot# 64314041; comp rvs cntrl 6.5x20mm st/rst cat# 115394 lot# 585860; comp lk scr 3.5hex 4.75x15 st cat# 180550 lot# 351840; comp lk scr 3.5hex 4.75x15 st cat# 180550 lot# 351840; comp lk scr 3.5hex 4.75x25 st cat# 180552 lot# 628410; mini humeral tray standard thickness +0 mm taper offset 40 mm diameter cat# 110031399 lot# 64314393; bearing standard 36 mm diameter cat# 110031418 lot# 64299809.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 02058, 0001825034 - 2020 - 02059, 0001825034 - 2020 - 02060, 0001825034 - 2020 - 02061, 0001825034 - 2020 - 02062, 0001825034 - 2020 - 02063, 0001825034 - 2020 - 02064.

Event Description

It was reported that a patient had an initial right reverse total shoulder arthroplasty.Four days later, the patient developed a small bowel obstruction requiring hospitalization and treatment of clear liquids, lovenox, morphine, and ondansetron.The adverse event was resolved two days later.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Constipation is the inability to pass stool and is very common in the days and weeks after surgery.The anesthetic causes the bowel to rest and can trigger constipation.Other factors which may lead to constipation in a perioperative patient include dehydration, not eating, and opioid medications, immobility, and a reduced diet.Ileus (sometimes known as a paralytic ileus) is the condition that describes the bowel is not contracting.This condition usually lasts from a few hours to a few days, but on rare occasions may last longer, and can lead to a small bowel obstruction.Constipation and ileus is a common procedural related complication that results from the use of anesthesia and pain management medications.As the complaint indicated the patient developed a post-operative complication of small bowel obstruction 4 days postop and was rehospitalized, it can be implied medical intervention was completed to treat this complication, therefore our complaint category, medical: procedure related would be appropriate.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records will not be performed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information is available at the time of this report.

• Brand Name: COMP LK SCR 3.5HEX 4.75X20 ST
• Type of Device: SHOULDER PROSTHESIS SCREW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10072516
• MDR Text Key: 193634009
• Report Number: 0001825034-2020-02065
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K132239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 180551
• Device Lot Number: 628250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 71