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

Model Number	N/A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Erosion (1750); Inflammation (1932); Pain (1994); Synovitis (2094)
Date of Event	09/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog#: 115310, comp rvrs shldr glnsp std 36mm, lot#: 670930.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: 0001825034-2024-00955, 0001825034-2024-00957.H3 other text: product location unknown.
Event or Problem 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.
Event or Problem Description
It was further reported that the patient was also revised for instability.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, d2, d4 (exp date, udi), g3, h1, h2, h3, h4, h6, h11.Reported event was confirmed as per medical records.Radiographs were provided and identified the following: limited evaluation of the glenoid and humeral hardware articulation secondary to superimposition.This would require additional views to fully evaluate.However, superior to the glenohumeral articulation which could represent chronically fractured bone fragments or heterotopic bone formation.Potentially, this could account for limited range of motion and patient's discomfort.Otherwise no obvious finding to account for the complaint.Medical records were reviewed and identified the following: stem stable and (retained), glenosphere and baseplate found stable, well fixed and revised, baseplate position found prominent, notching, placement of bit superior on the glenoid in light of this, a relocation to the inferior portion of the glenoid was performed.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported event is attributed to failure to follow instructions as the operative noted indicated the baseplate placement was too superior, which caused scapular notching.Per surgical technique the final construct should be checked for impingement.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.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER PLATE BASE GLENOSPHERE
• Common Device Name: 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: 19047364
• Report Number: 0001825034-2024-00956
• Device Sequence Number: 15594808
• Product Code: KWS
• UDI-Device Identifier: 00880304475342
• UDI-Public: (01)00880304475342(17)260125(10)415440
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2026
• Device Model Number: N/A
• Device Catalogue Number: 115330
• Device Lot Number: 415440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White