MAUDE Adverse Event Report: ZIMMER BIOMET, INC. +3MM OFFSET POLY LINER 40; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Joint Dislocation (2374); No Information (3190)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00434904011, tm reverse 40mm glenosphere, 63286804; 00434901500, base plate 15 mm, 63319128.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001822565-2017-06806.

Event Description

It was reported that the patient underwent a primary reverse shoulder arthroplasty.Subsequently, the patient was revised due to dislocation and loosening.A custom, extended glenosphere was implanted.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.

Event Description

It was reported that the patient underwent a primary reverse shoulder arthroplasty.Subsequently, the patient was revised to a custom extended glenosphere implant due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon reassessment, it was identified that the product was not involved in the reported event.The report should be voided.

• Brand Name: +3MM OFFSET POLY LINER 40
• 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: 7051150
• MDR Text Key: 92714881
• Report Number: 0001822565-2017-08016
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00434904003
• Device Lot Number: 62816886
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR