MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER STANDARD TAPER ADAPTOR; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Weakness (2145); Tingling (2171); Numbness (2415)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog # 113053, lot # 101640, description: comprehensive shoulder modular head variable offset; 113956, 468830, hybrid glenoid base 4 mm large; pt-113950, 304740, pt hybrid glenoid post regenerex.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 1825034-2017-02431 / 02432 / 02433.

Event Description

It was reported that a patient enrolled in a clinical study underwent a right total shoulder arthroplasty and at three (3) months post-operative follow-up reports experiencing pain, signs of supraspinatus/greater tuberosity, acromioclavicular joint tenderness, biceps tendon tenderness, subacromial crepitus, and onset of numbness in fingers that lasted for approximately nine (9) months, before resolving.At two (2) year post-operative follow-up, acromioclavicular joint tenderness, biceps tendon tenderness, subacromial crepitus, occasional numbness at the bottom of right forearm through fingers, pain, instability and muscle spasm for the past six (6) months along with intermittent throbbing pain, metallic taste in mouth, weakness and muscle fatigue in right arm/shoulder and impingement were noted.Patient has been indicated for an ultrasound to evaluate the rotator cuff and biceps.Attempts have been made and additional information on the reported event is unavailable at this time.

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.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is 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: COMPREHENSIVE SHOULDER STANDARD TAPER ADAPTOR
• 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: 6472272
• MDR Text Key: 72119444
• Report Number: 0001825034-2017-02434
• 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: 02/09/2018

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: 118001
• Device Lot Number: 381590
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: 02/09/2018
• Supplement Dates FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2015
• 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: 56 YR
• Patient Weight: 136