MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SHOULDER SYSTEM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 00466, 0001825034 - 2018 - 00467, 0001825034 - 2018 - 00468, 0001825034 - 2018 - 00469.Concomitant: 113956 lg hybrid glenoid base 4mm lot 305190; pt-113950 pt hybrid glen post regenerex lot 112860; 113634 comp primary stem 14mm mini lot 257150; 113063 versa-dial 54x21x64 hum head lot 779770.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported that patient underwent right shoulder procedure and subsequently is experiencing more pain than expected, range of motion is better but painful and weakness in the shoulder, specific to the deltoid muscle.No further information is available at this time.

Manufacturer Narrative

Reported event was confirmed by review of x-rays and medical records.Physical therapy notes imply that patient was aggressive with therapy and repeatedly reminded to follow post-op protocols.X-ray report findings include: generalized regions of lucency noted in the greater and lesser tubercles as well as likely in the glenoid.This is not sharply demarcated/periprosthetic but appears generalized in this region.May suggest stress shielding/bone resorption and can contribute to pain.Questionable joint bodies/synovitis.Also there is suspected calcific tendinitis, another cause of pain.Finally, widened ac joint can also be related to distal clavicle osteolysis which can be related to prior trauma and may be a source of pain if not chronic.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.Investigation results concluded that the reported event was due to patient non-compliance with post-operative physical therapy plan.A summary of the investigation has been sent to the complainant.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

This follow up report is being submitted to report additional information.

• Brand Name: COMPREHENSIVE SHOULDER SYSTEM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7238816
• MDR Text Key: 98932471
• Report Number: 0001825034-2018-00470
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/22/2022
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 225610
• Other Device ID Number: (01) 00880304217249
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 95