MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN GLENOID; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032)

Event Date 06/08/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.H3 other text : unknown.

Event Description

It was reported that the patient underwent initial surgery approximately 10 months ago.Subsequently, the patient was revised due to a mal-positioned glenoid component which was confirmed by radiographs.The patient was experiencing limited range of motion.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).Updated.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.It was communicated that the glenoid component was mal-positioned; however, without more information regarding if the implant became malpositioned in vivo or when initially implanted, 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: UNKNOWN GLENOID
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17277681
• MDR Text Key: 318564463
• Report Number: 0001822565-2023-01793
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 08/24/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male