MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE HUMERAL POLY LINER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00434903611, glenosphere, 63106907.00434901500, base plate,63207865.00434903603, poly liner, 63096950.00435001313, humeral stem, 62983978.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: 0001822565 - 2019 - 02481, 0001822565 - 2019 - 02482, 0001822565 - 2019 - 02484.

Event Description

It has been reported that patient had initial left reverse shoulder surgery.During the three (3) year post surgery clinical study survey, patient reportedly was no longer satisfied with the shoulder procedure, had difficulty performing daily living activities, and along with a 10% (poor) rating for shoulder normalcy during the study.Patient was unable to attend physician clinical exam, therefore no images or physician exam was performed during this time period.No additional patient consequences were reported.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

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

Reported event was unable to be confirmed due to limited information received from the customer.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no complication noted during the procedure.Device history record was reviewed and no discrepancies were found.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.

Event Description

No further event information available at the time of this report.

• Brand Name: TM REVERSE HUMERAL POLY LINER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8699326
• MDR Text Key: 148000811
• Report Number: 0001822565-2019-02483
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2019

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: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00434903603
• Device Lot Number: 63096950
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 06/14/2019; 07/30/2019
• Supplement Dates FDA Received: 07/11/2019; 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 93