MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SM HYBRID GLENOID BASE 4MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES

Model Number 113952

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product was initial reported on mfr: 0001822565-2022-02450.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02404; 0001825034-2022-02405; 0001825034-2022-02406.Medical products: item#: 113048, versa-dial 46x27x46 hum head; lot#: 572420; item#: pt-113950, pt hybrid glen post regenerex; lot#: 960770; item#: 118001, versa-dial/comp ti std taper; lot#: 057540; item#: 113653, comp primary stem 13mm std; lot#: 987670.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a right shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision surgery due to bone erosion and instability on an unknown date.However, no revision procedure has been reported to date.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02404-1 0001825034-2022-02405-1 the following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6 no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.It remains that 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.

Event Description

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

• Brand Name: SM HYBRID GLENOID BASE 4MM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES
• 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: 15670160
• MDR Text Key: 302398314
• Report Number: 0001825034-2022-02403
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304462625
• UDI-Public: (01)00880304462625(17)220809(10)539300
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2022
• Device Model Number: 113952
• Device Catalogue Number: 113952
• Device Lot Number: 539300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization