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

Model Number N/A

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 115732,comprehensive nano humeral component pps,410710, 113952,modular hybrid glenoid base, 932710, pt-113950,modular hybrid glenoid post¿regenerex, 573810, 118001, comprehensive standard taper adaptor, 076840.Report source: (b)(6).Complaint sample was evaluated and the reported event was not confirmed.As per the operative records and x-rays provided, the rotator cuff was normal.Humeral head had normal contour and the glenoid was normal.There were no complications, deviations from surgical technique, or delays in the procedure.As per the x-ray review of 6-months post initial surgery, no glenoid and humeral radiolucency, subsidence, osteolysis, migration, integrity is intact and no bone fracture.Dhr was reviewed and no discrepancies were found.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 02385, 0001825034 - 2019 - 02386, 0001825034 - 2019 - 02388.This product was previously reported under mfr 0001825034 - 2018 - 10770.

Event Description

It has been reported that patient had initial comprehensive shoulder arthroplasty.Subsequently, six (6) months post initial surgery patient suffered from patient suffered shoulder pain, instability, tenderness, decrease in adls and impingement.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The correct notification date for 0001825034-2019-02389 is may 1, 2019 not july 11, 2018.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Correction: the implant date is (b)(6) 2017 and not (b)(6) 2017 which was previously reported.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 02386, 0001825034 - 2019 - 02388, 0001825034 - 2019 - 02385, 0001825034 - 2019 - 04047.

Event Description

It has been reported that patient had initial comprehensive shoulder arthroplasty.Subsequently, patient suffered shoulder pain, instability, tenderness, decrease in adls and impingement.No additional patient consequences were reported.

• Brand Name: VERSA-DIAL 42X18X46 HUM HEAD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8657758
• MDR Text Key: 146622865
• Report Number: 0001825034-2019-02389
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K060716
• 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: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• 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: 113032
• Device Lot Number: 842820
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 80