MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 10MM MICRO; PROSTHESIS, SHOULDER

Catalog Number	113610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 2.5 years post implantation due to disassociation of the glenoid and metal post.During the revision, found the stem with significant metallosis type of debris around it, resorption noted around the neck of the humerus and the calcar, synovitis resulting in a complete synovectomy, a piece of the polyethylene baseplate that fractured off and was left attached to the ingrowth post, wear to the glenoid, and significant glenoid damage with posterior erosion and a b2 type of configuration.All components were removed without complication and competitor product was implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: sm hybrid glenoid base 4mm cat# 113952 lot#676850, pt hybrid glen post regenerex cat# pt-113950 lot#757630.Versa-dial 42x21x43 hum head cat# 113034 lot# 807310, versa-dial/comp ti std taper cat# 118001 lot# 027330.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01733, 0001825034 - 2022 - 01734, 0001825034 - 2022 - 02700, 0001825034 - 2022 - 02701.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: component code: proposed code: mechanical (g04)- stem.Visual examination of the provided photo identified explanted products.However, as the parts were not returned, further analysis could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 1 month prior to revision: patient indicated when hanging clothes up when felt a pop.Range of motion issues and significant pain and weakness were also noted.Week prior to revision: ct found glenoid dislodged and loose in the anterior joint space surrounded by contrast.Revision: it was noted the stem had significant metallosis type of debris around it and resorption around the neck of the humerus.Stem was removed but appeared to be well fixed.It was also noted that the polyethylene over mold fractured at the interface with the post.Significant wear of the glenoid component was noted.The glenoid was significantly damaged with posterior erosion.A definitive root cause cannot be determined.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: COMP PRIMARY STEM 10MM MICRO
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 15887871
• Report Number: 0001825034-2022-02699
• Device Sequence Number: 17418989
• Product Code: KWS
• UDI-Device Identifier: 00880304554115
• UDI-Public: (01)00880304554115(17)291023(10)178990
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K060692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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 Catalogue Number: 113610
• Device Lot Number: 178990
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 81 KG