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

Model Number N/A

Device Problems Fracture (1260); Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical product: catalog #: 110031428, cr vivacit-e 40mm brng +3, lot # 65164152.Catalog #: 110031428, cr vivacit-e 40mm brng +3, lot # unknown.Catalog #: unknown, unknown tray, lot # unknown.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02574, 0001822565-2022-02576, 0001822565-2022-02577.

Event Description

It was reported that during a surgery before implantation it was found that the humeral bearing poly was shifting roughly 1-3mm in either direction.The bearing was then disassociate from the humeral tray with the surgeon's hands, and the humeral bearing broke off.The surgron then proceeded to try another poly.It did the exact same thing, except the tabs did not break on the second poly.We then tried a third 40 +3 poly which did the exact some thing as the previous two, except the doctor left the bearing in the patient and finished the case.Attempts have been made and there is no further information at this time.

Event Description

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

Manufacturer Narrative

(b)(4).Updated: b4, b5, g3, h1, h2, h3, h6, h10.Reported event was unable to be confirmed as visual examination of the returned products show damage to the backside / locking features.Damage was noted secondary to testing of bearing toggle.One of the clips is fractured on a product.As damage was noted, dimensional analysis was not performed.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.This event was further investigated through the capa process.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.

Manufacturer Narrative

(b)(4).After further review, it was determined that this product is a comprehensive mini.The comprehensive mini product line is not same or similar to the comprehensive reverse product line.Further, this product's malfunction did not cause a serious injury and has not in the past.Therefore, this should be not reportable.

Event Description

After further review, it was determined that this product should be not reportable.

• Brand Name: CR VIVACIT-E 40MM BRNG +3
• Type of Device: EXTREMITIES IMPLANTS
• 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: 15373280
• MDR Text Key: 301282429
• Report Number: 0001822565-2022-02575
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00887868231599
• UDI-Public: (01)00887868231599(17)261203(10)65163939
• 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: Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031428
• Device Lot Number: 65163939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Sex: Male