MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Concomitant medical products: poly liner, catalog# 00434903600, lot#:63063466; humeral stem spacer, catalog#:00434903909, lot#:63069520; humeral stem diameter, catalog#:00434901413, lot#:62908447; humeral stem, catalog#:00434901213, lot#:63028466; bone cement, catalog#: 00110201200, lot#: 62774067; reverse screw system, catalog#: 0104223027, lot 2784834; reverse screw system, catalog #0104223030, lot 2798845; baseplate, catalog#:00434901500, lot#:63012728.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted at this time.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: 0001822565-2017-03461, 0001822565-2017-03463, 0001822565-2017-03470, 0001822565-2017-03471, 0001822565 - 2017 - 03473.

Event Description

It is reported that the patient is experiencing pain and limited range of motion in the operative shoulder approximately twenty (20) months post-operatively of a left reverse shoulder arthroplasty.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 as no trends were identified.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-03461, 0001822565-2017-03463, 0001822565-2017-03470, 0001822565-2017-03471, 0001822565-2017-03473.

• Brand Name: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6731886
• MDR Text Key: 80670192
• Report Number: 0001822565-2017-05018
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00434903611
• Device Lot Number: 62959387
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 10/30/2017
• Supplement Dates FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2015
• 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): Required Intervention
• Patient Weight: 113