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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The following sections could not be completed with the limited information provided.Concomitant devices ¿ versa-dial comprehensive standard adaptor catalog #: 118001 lot #: 303560, hybrid glenoid base 4mm catalog #: 113954 lot #: 985500, pt hybrid glenoid post catalog #: pt-113950 lot #: 762830.This report is number 2 of 4 mdrs filed for the same patient (reference 0001825034-2017-03360 / 03362 / 03363).

Event Description

It is reported that the patient underwent a total shoulder arthroplasty.Subsequently, pain, tenderness, impingement, subacromial crepitus, and a infraspinatus fosia deformity were noted at six (6) week post-operative follow-up.Continued pain, biceps tendon tenderness, impingement, infraspinatus atrophy, and instability were noted at three (3) month post-operative follow-up.Pain, tenderness, impingement, and instability were noted at one (1) year post-operative follow-up.Tenderness and instability were still noted to persist at two (2) year post-operative follow-up.Lastly, a small luceny at the inferior aspect of the implant was noted at thirty-four months post-operatively.However, the condition is noted to be tolerated and there is no plan to revise the patient or otherwise treat them.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.X-ray reviewer stated "imaging findings are thought to confirm the reported event.Patient risk factors (acromioclavicular hypertrophy and cortical irregularity anterior humeral head), as well as imaging findings of anterior / superior subluxation of humeral head known are known to be associated with reported events of supraspinatus / greater tuberosity tenderness, biceps tendon tenderness (or rupture), impingement and instability." 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 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: 6580346
• MDR Text Key: 75597557
• Report Number: 0001825034-2017-03361
• 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: 05/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 113055
• Device Lot Number: 705460
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2013
• 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: 81