MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL SHOULDER MODULAR HEAD WITH VARIABLE OFFSET; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Weakness (2145)

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is indicated that the product will not be returned to zimmer biomet for investigation, as the devices remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices ¿ comprehensive primary mini length shoulder stem catalog #: 113628 lot #: 646590, comprehensive shoulder standard taper adaptor catalog #: 118001 lot #: 625050, hybrid small 4mm glenoid base catalog #: 113952 lot #: 856280, pt hybrid regenerex porous glenoid post catalog #: pt-113950 lot #: 868290.This report is number 1 of 5 mdrs filed for the same patient (reference 0001825034-2017-03514 / 03515 / 03517 / 03518).

Event Description

It is reported that the patient underwent a right total shoulder arthroplasty.Subsequently, pain, impingement, and 2 mm of glenoid radiolucency were noted at six (6) week post-operative follow-up.The radiolucency reportedly resolved.Unusual pain, incision line tenderness, and weakness were noted at three (3) month post-operative follow-up.The pain reportedly persisted unchanged until the six (6) month post-operative follow-up.The patient was also prescribed additional physical therapy to treat the weakness.Glenoid radiolucency was again noted eleven (11) months post-operatively.Lastly, the patient experienced tenderness at the distal portion of the surgical incision two years following shoulder arthroplasty attributable to a keloid.The surgeon has no plans to revise or otherwise treat the patient, but the patient will continue to be monitored.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.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.

• Brand Name: VERSA-DIAL SHOULDER MODULAR HEAD WITH VARIABLE OFFSET
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6607772
• MDR Text Key: 76518857
• Report Number: 0001825034-2017-03516
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 113034
• Device Lot Number: 360110
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2014
• 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
• Patient Outcome(s): Other
• Patient Weight: 73