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

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under possible adverse effects: loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.Dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.Literature: wiater, b.P., baker, e.A., salisbury, m.R., koueiter, d.M., baker, k.C., nolan, b.M., & wiater, m.J.(2015).Elucidating trends in revision reverse total shoulder arthroplasty procedures: a retrieval study evaluating clinical, radiographic, and functional outcomes data.Journal of shoulder and elbow surgery, 24(12), 1915-1925.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.Zimmer biomet complaint number: (b)(4).This report is being submitted late as it has been identified in remediation.

Event Description

Information was received based on review of a journal article entitled, "elucidating trends in revision reverse total shoulder arthroplasty procedures: a retrieval study evaluating clinical, radiographic, and functional outcomes data".The article addresses that three (3) patients required a revision due to instability.There has been no further information provided and the patients outcome is unknown.

• Brand Name: UNKNOWN COMPREHENSIVE REVERSE SHOULDER
• 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: 6964553
• MDR Text Key: 89814755
• Report Number: 0001825034-2017-09301
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2015
• 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: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention