MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LG HYBRID GLENOID BASE 4MM; SHOULDER, PROSTHESIS

Catalog Number 113956

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 06/16/2022

Event Type  Injury  

Event Description

It was reported that the patient was revised due to dislocation.The patient had underwent a previous subscapularis repair after dislocation/ instability.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: lg hybrid glenoid base 4mm cat: 113956 lot: 113956.Versa-dial 50x21x57 hum head cat: 113053 lot: 022950.Compr nano hmrl pps 40mm cat: 115740 lot: 239820.Versa-dial/comp ti std taper pr adaptor cat: 118001 lot: 090990.Pt hybrid glen post regenerex generex cat: pt-113950 lot: 451180.Report source: foreign: uk.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receipt of additional information it has been determined that the device was previously investigated on medwatch#: 0001825034-2020-01177.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: LG HYBRID GLENOID BASE 4MM
• Type of Device: SHOULDER, PROSTHESIS
• 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: 15056774
• MDR Text Key: 296176524
• Report Number: 0001825034-2022-01653
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K193038
• 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: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113956
• Device Lot Number: 113956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 127 KG