MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE PRIMARY SHOULDER STEMS; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 09/24/2014

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).Foreign: the event occurred in (b)(6).The device was not returned for evaluation due to unknown location.Review of the device history record (dhr) found no deviations or anomalies.Review of complaint history identified eleven other complaints for part number and no complaints for lot number.Without the opportunity to evaluate the device, the complaint was not confirmed and root cause could not be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Associated risk table lists "miscellaneous user needs (general post operative pain )¿.Following review, no new risks were identified.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: 0001825034 -2017-09650/ 09651/ 09652/ 09653/ 09654/ 09655/ 09656/ 09657.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that during a six (6) month follow up visit for rotator cuff arthroplasty performed on (b)(6) 2014, the patient reported to experience pain at a level 8 out of 10.The patient required unspecified narcotic pain medication at 1 pill a day on average.The patient indicated that they were unable to wash their back, unable to manage toileting, unable to reach a high shelf, unable to lift 10 pounds above their shoulder, unable to throw a ball, and unable to sport walk.No additional information was available and the patient outcome is unknown.Attempts have been made and no further information has been provided.

• Brand Name: COMPREHENSIVE PRIMARY SHOULDER STEMS
• 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: 7103721
• MDR Text Key: 94351540
• Report Number: 0001825034-2017-09649
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: PK060692
• 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: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 113630
• Device Lot Number: 951390
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2014
• 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 Age: 75 YR
• Patient Weight: 56