MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVRS HUM POLY LINER/INLAY; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Concomitant medical products: 00434901413, tm reverse stem, 62459954; 00434902502, tm reverse long post glenoid , 62428982; 00434903611, tm reverse glenosphere 36 mm diameter, 62501364.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-07079, 0001822565-2017-07081, 0001822565-2017-07082.

Event Description

It was reported that the patient underwent an initial shoulder arthroplasty procedure.Subsequently, the patient experienced continuous pain and dysfunction post-implantation.The patient has been indicated for a revision procedure.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay a additional information, which was unknown at the time of the initial medwatch.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient was revised to address continuous pain and right side shoulder dysfunction.Loosening of the glenoid was reported in the study as well.X-ray revealed implant migration and impingement of the humeral prosthesis on the inferior lip of the glenoid.No further information has been made available.

Manufacturer Narrative

This report is being submitted to relay corrected information.Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.

• Brand Name: TM REVRS HUM POLY LINER/INLAY
• 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: 6954993
• MDR Text Key: 89499888
• Report Number: 0001822565-2017-07080
• 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: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00434903603
• Device Lot Number: 62465423
• Other Device ID Number: (01) 00889024269064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2013
• 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: 74 YR
• Patient Weight: 77