MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HYBRID GLENOID BASE 4MM SMALL ARCOM; EXTREMITIES IMPLANTS

Model Number N/A

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

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported that the initial right shoulder arthroplasty approximately 9 years ago.Subsequently about a month ago the patient reported unusual pain and a decrease in range of motion with referral for consultant and unknown treatment.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).A2:dob 1953.G2: uk.D10 - medical product: catalog #: 115730, compr nano hmrl pps 30mm, lot # 659640.Catalog #: 118001, versa-dial/comp ti std taper, lot # 182780.Catalog #: 113022, versa-dial 38x19x39 hum head, lot # 395410.Catalog #: pt-113950, pt hybrid glen post regenerex, lot # 849750.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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: 0001825034-2024-00795, 0001825034-2024-00803, 0001825034-2024-00804, 0001825034-2024-00806.

• Brand Name: HYBRID GLENOID BASE 4MM SMALL ARCOM
• 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: 18953816
• MDR Text Key: 338276896
• Report Number: 0001825034-2024-00805
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113952
• Device Lot Number: 729090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/21/2024
• 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
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 64 KG