MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COMPREHENSIVE MODULAR STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tingling (2171); Ambulation Difficulties (2544)

Event Date 04/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown, unknown humeral bearing, unknown, unknown, unknown baseplate, unknown, unknown, unknown glenosphere, unknown, unknown, unknown central screw, unknown, unknown, unknown peripheral screw, unknown, unknown, unknown comprehensive proximal body, unknown, unknown, unknown humeral tray, unknown.Report source, foreign - the event occurred in the (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the part and lot numbers of the device involved in the event are unknown.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.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 03441, 0001825034 - 2018 - 03442, 0001825034 - 2018 - 03443, 0001825034 - 2018 - 03444, 0001825034 - 2018 - 03445, 0001825034 - 2018 - 03446, 0001825034 - 2018 - 01520.Product location unknown.

Event Description

It was reported that a patient underwent right shoulder surgery.Subsequently, post-operative pain and other experiences were reported on the quick dash questionnaire.At the six month follow-up, the patient was unable to do heavy chores, was unable to wash back, was unable to do recreational activities, was moderately limited with daily activities, experienced moderate pain, and experienced moderate tingling.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN COMPREHENSIVE MODULAR STEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7525685
• MDR Text Key: 108641023
• Report Number: 0001825034-2018-03447
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR
• Patient Weight: 58