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

Model Number N/A

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

Patient Problems Pain (1994); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: ni, simplex p cement, lot # ni.Catalog #: us115740, comprehensive nano, lot # 752510.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned for evaluation, as it remains implanted.Device history records were reviewed and no discrepancies were found.Review of complaint history determined that no further actions are required.Root cause was unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02767, 02779, 02781, 02789.

Event Description

It was reported that a patient underwent an initial right shoulder arthroplasty.Subsequently, the patient experienced pain at night and mild instability noted at three (3) month post-operative follow-up.Additionally, at one (1) year post-operative follow-up it was noted that the patient was experiencing worsening pain in their shoulder, beginning nine months post-operatively; supraspinatus/greater tuberosity tenderness; acromioclavicular joint tenderness; biceps tendon tenderness; and impingement.Outcome of treatment is pending at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Adverse event and product problem.Concomitant medical products - simplex p cement, cat#: ni, lot # ni.Comprehensive nano, cat#: us115740, lot # 752510.Versa-dial humeral head, cat#: 113063, lot#: 429880.Hybrid glenoid base, cat#: 113956, lot#: 900480.Pt hybrid glenoid regenerex post, cat#: pt-113950, lot#: 970040.Root cause remains undetermined.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.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.

Event Description

It was reported that a patient underwent an initial right shoulder arthroplasty.Subsequently, the patient experienced pain at night and mild instability noted at three (3) month post-operative follow-up.Additionally, at one (1) year post-operative follow-up it was noted that the patient was experiencing worsening pain in their shoulder, beginning nine months post-operatively; supraspinatus/greater tuberosity tenderness; acromioclavicular joint tenderness; biceps tendon tenderness; and impingement.Furthermore, during the patient's two (2) year post-operative follow-up the patient reported mild pain (1 out of 10), mild instability (0-1cm translation), deltoid tenderness, as well as numbness across shoulder into the deltoid.The patient also received a diagnosis of cervical stenosis but has yet to follow up with a neurologist.Outcome of treatment is pending at this time.

Manufacturer Narrative

This follow up report is being submitted to relay additional information: x-rays were received and reviewed.Per the review, no cause for pain and numbness is identified nor anything visualized that would cause nerve damage.Overall fit, size, and orientation appear unremarkable.Bone quality and patient anatomy appear unremarkable.There is advanced osteoarthritis of the acromioclavicular joint.Root cause remains undetermined; however, it was identified that the patient has cervical stenosis which may be a contributing factor to radiating pain and numbness.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 SYSTEM 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: 6530103
• MDR Text Key: 73949208
• Report Number: 0001825034-2017-02767
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• 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: 118001
• Device Lot Number: 085220
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2016
• 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: 69 YR
• Patient Weight: 125