MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR VIVACIT-E 40MM BRNG +3; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994)

Event Date 01/25/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a revision procedure due to infection.All components were removed and an antibiotic cement spacer was placed.The patient is being currently being considered for a custom device.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown humeral stem, cat#: ni, lot#: ni.Unknown humeral liner, cat#: ni, lot#: ni.Unknown glenoid head, cat#: ni, lot#: ni.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: 0001822565 - 2022 - 01369, 0001822565 - 2022 - 01371, 0001822565 - 2022 - 01372.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).

Event Description

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).

Manufacturer Narrative

(b)(4).D2: phx.D10: cr 40mm glenosphere +3mm cocr cat# 110030777 lot# 64328699, mini tray std cocr +0 offset cat# 110031399 lot# 64957156, comp aug mini bsplt w tpr md cat#110032420 lot# 64089391, comp rvs cntrl 6.5x30mm st/rst cat#115396 lot# 576760, comp lk scr 3.5hex 4.75x30 st cat# 180553 lot# 246200, comp lk scr 3.5hex 4.75x35 st cat# 180554 lot# 698810, comp lk scr 3.5hex 4.75x25 st cat# 180552 lot# 591530, comp lk scr 3.5hex 4.75x15 st cat# 180550 lot# 419550, unk humeral stem cat# unk lot# unk.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: 0001822565-2022-01371-3, 0001822565-2022-01372-3.

Event Description

It was reported that a patient underwent a revision procedure approximately 10 months postimplantation due to infection, persistent pain and loosening of hardware.All components were removed and an antibiotic spacer was placed.Significant discolored bio-film type tissue was present upon removal of the humeral tray.Humeral stem was removed without significant bone loss, glenoid removed without complication.The baseplate was grossly loose prior to removal, with significant bone loss, soft tissue debridement and bio-film tissue present.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.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.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: CR VIVACIT-E 40MM BRNG +3
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14349683
• MDR Text Key: 291342589
• Report Number: 0001822565-2022-01370
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00887268231599
• UDI-Public: (01)00887268231599(17)250131(10)64525936
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031428
• Device Lot Number: 64525936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 05/23/2022; 05/27/2022; 05/27/2022; 07/07/2022
• Supplement Dates FDA Received: 05/24/2022; 06/15/2022; 06/21/2022; 07/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.; SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 103 KG