MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR VIVACIT-E 36MM BRNG STD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)

Event Date 02/05/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a right reverse total shoulder arthroplasty.Approximately 1 month post implantation, the patient was revised due to pain, scapular notching, and dissociation of the glenosphere from the baseplate as noted on x-ray.During the revision, severe metallosis was noted throughout the joint due to severe wear of the poly and baseplate as well as the dislocation and disassociation.Significant bone loss and erosion were also noted.The stem was left intact, and the glenoid was converted to a hemiarthroplasty with a new head and taper placed.

Manufacturer Narrative

(b)(4).Product code - phx.Concomitant medical products: 110031402, humeral tray, 64437435.110032410, baseplate, 64394791.115310, glenosphere, 290790.180551, screw, 294290.180553, screw, 380950.180553, screw, 006800.180550, screw, 758340.115395, central screw, 071640.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 will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: office visit (approximately three weeks prior to revision): presents with pain, specifically in the anterior region of the shoulder.The patient reports sleeping in her recliner when she felt the pain approximately two months prior.X-rays show dissociation of the glenosphere from the baseplate with no apparent loosening of the humeral component or baseplate.Scapular notching is present with multiple loose bodies around the joint.Plan for revision.- revision, hemiarthroplasty: revision due to dislocation and disassociation of the glenoid components.Severe metallosis noted throughout the joint.Severe wear of the inferior aspect of the poly as well as some wear of the metal of the humeral tray.Humeral stem found stable.Erosion of the cortical bone at the lesser tuberosity with stem visible through a cortical window.Severe wear of the baseplate noted with the central screw hole also malformed.¿there had been melting of the posterior aspect of the baseplate and then it had reached annealed with metal covering the posterior locking screw in the baseplate.This made that screw inaccessible.¿ ¿between the patient¿s pre-existing glenoid bone deformity as well as the bone loss with removal of the failed baseplate, there was not enough remaining native glenoid bone to perform a reverse shoulder arthroplasty even with a large augment.¿ hemi components placed without complication.The patient to remain non-weight bearing with no shoulder motion for four weeks then proceed with rom exercises.- x-rays: reverse total shoulder arthroplasty of the right shoulder with implant disassembly of the glenosphere, now located along the lateral aspect of the humeral component.Bony remodeling of the distal clavicle and ac joint, acromion with extensive curvilinear calcification of the joint capsular which presumably relates to patient's known history of metallosis.Osteopenia is present.Central screw home affirmation cannot be confirmed on x-ray.Taper adapter not clearly seen.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CR VIVACIT-E 36MM BRNG STD
• 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: 16474062
• MDR Text Key: 310586326
• Report Number: 0001822565-2023-00532
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00887868231551
• UDI-Public: (01)00887868231551(17)250923(10)64833589
• 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
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031424
• Device Lot Number: 64833589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• 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 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 67 KG