MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE VERSA-DIAL 42X18X46 MODULAR HUMERAL HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Unstable (1667); Insufficient Information (3190); Migration (4003)

Patient Problem Pain (1994)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: 115736 compr nano hmrl pps 36mm 965150, 118001 versa-dial/comp ti std taper 538320, 113954 md hybrid glenoid base 4mm 654960 , pt-113950 pt hybrid glen post regenerex 628870.Once the evaluation is completed, a supplemental med watch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04084, 0001825034-2018-04088, 0001825034-2018-04089.

Event Description

It was reported that the patient began experiencing unusual left shoulder pain after two (2) years, eleven (11) months post primary surgery.The pain was reported to be not device related.A revision procedure is indicated, but has not occurred.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

The follow up report is being submitted to relay additional information received.The complaint is confirmed based on the information provided.X- ray review shows no evidence of loosening or impingement.Review of device history records found these units were released to distribution with no related deviations or anomalies.Root cause could not be determined.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

It was reported that the patient began experiencing unusual left shoulder pain, impingement and instability after 6 months post primary surgery and was revised for loosening, due to lack of bone in growth into humeral component.No more additional information available.

Event Description

Returned product was evaluated.No more additional information is provided.

Manufacturer Narrative

The complaint product were returned for evaluation.The humeral head, it¿s taper and the taper of the nano are in good condition.Product id measurements were done on the nano and humeral head.All measurements are in spec.The nano component has noted bony ingrowth on it.This additional information received does not change any previously reported investigation results.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.

• Brand Name: COMPREHENSIVE VERSA-DIAL 42X18X46 MODULAR HUMERAL HEAD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7615686
• MDR Text Key: 111615753
• Report Number: 0001825034-2018-04086
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2018

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 113032
• Device Lot Number: 794620
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 09/05/2018; 12/20/2018
• Supplement Dates FDA Received: 09/20/2018; 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 95