MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM ÿ GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 00434903611

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01292.Device product code: phx.Item# 00434903606; lot# 62816883.Item# 00434901500; lot# 63257424.Item# 00434901213; lot# 62920396.Foreign: event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Event Description

It was reported that the patient was revised approximately five (5) years and six (6) months post-implantation due to dislocation.Surgeon is considering the cause for dislocation was possibly over tension.Patient currently has a spacer mold implanted while waiting for a pmi device.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2 upon receiving additional information of the reported event, it was determined to be not reportable.Examination of x-rays provided indicated loosening of the baseplate that had caused subluxation.The initial report should be voided.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.

Event Description

No further event information available at the time of this report.

• Brand Name: 36MM ÿ GLENOSPHERE
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 14307193
• MDR Text Key: 290951210
• Report Number: 0001822565-2022-01293
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00889024269088
• UDI-Public: (01)00889024269088(17)250630(10)63085423
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00434903611
• Device Lot Number: 63085423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male