MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE; EXTREMITIES IMPLANTS

Model Number N/A

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

Patient Problems Ossification (1428); Erosion (1750); Inflammation (1932); Pain (1994); Synovitis (2094)

Event Date 09/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4), d10 - medical product: catalog #: 115330, comp rvrs shdr glen bsplt +ha, lot # 415440.Catalog #: 118001, versa-dial/comp ti std taper, lot # 411920.Catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 541780.Catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 472190.Catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 593030.Catalog #: 115397, comp rvs cntrl 6.5x35mm st/rst, lot # 172790.Catalog #: 180561, comp nlk scr 3.5hex 4.75x35 st, lot # 251830.Catalog #: 180560, comp nlk scr 3.5hex 4.75x30 st, lot # 541780.Catalog #: 113653, comp primary stem 13mm std, lot # 921870.Catalog #: 115370, comp rvs tray co 44mm, lot # 577900.Catalog #: xl-115363, arcom xl 44-36 std hmrl brng, lot # 355910.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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: 0001825034-2024-00956, 0001825034-2024-00957 h3 other text : product location unknown.

Event Description

It was reported patient underwent left reverse total shoulder approximately 8 years ago.Subsequently about a year later the patient underwent a revision due to bone erosion (notching) ho, and poor baseplate positioning.The patient retained the well fixed stem, but revised humeral tray & bearing.Glenosphere components revised to competitor products.No further information is known.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE
• Type of Device: EXTREMITIES IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19047374
• MDR Text Key: 339432321
• Report Number: 0001825034-2024-00955
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 670930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White