MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL 54X24X58 HUM HEAD; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned [because it is still implanted] to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 1825034-2017-02332, 02333, 02334, 02335, 02336.

Event Description

It is reported that the patient underwent right shoulder arthroplasty.On the date of surgery, patient had shortness of breath for 1 day, unrelated to device or procedure.Approx 3 weeks post-implantation, patient experienced numbness in the thumb and sharp pain in the neck which resolved after 3 days when patient stopped wearing a sling.Approx 6 weeks post-implantation, the patient experienced impingement and mild pain which had resolved by the 3-month follow-up.Approx 1 year post-implantation, patient reported ongoing unusual shoulder pain, bilateral hand pain, right long trigger digit, and hesitancy to perform certain range of motion activities with the operative shoulder.Right hand pain is reported as worse than the left.Outcome of treatment is pending, but pain in shoulder appears to be improving.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to 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 is reported that the patient underwent right shoulder arthroplasty.On the date of surgery, patient had shortness of breath for 1 day, unrelated to device or procedure.Three weeks post-implantation, patient experienced numbness in the thumb and sharp pain in the neck which resolved after 3 days when patient stopped wearing a sling.Six weeks post-implantation, the patient experienced impingement and mild pain which had resolved by the 3-month follow-up.Three months post-operatively, the patient experienced instability, but had resolved by 1 year post-operative follow-up.One year post-implantation, patient reported ongoing unusual shoulder pain, bilateral hand pain, right long trigger digit, and hesitancy to perform certain range of motion activities with the operative shoulder.Right hand pain is reported as worse than the left.Outcome of treatment is pending, but pain in shoulder appears to be improving.

• Brand Name: VERSA-DIAL 54X24X58 HUM HEAD
• 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: 6452711
• MDR Text Key: 71466470
• Report Number: 0001825034-2017-02334
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 113065
• Device Lot Number: 838360
• Other Device ID Number: SEE H10 SUMMARY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 04/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2015
• 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 Age: 68 YR
• Patient Weight: 118