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

Catalog Number 00434903611

Device Problems Material Erosion (1214); Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).Concomitant products: base plate uncemented cat: 00434903811 lot: 60729065.Humeral stem spacer size 9 cat: 00434903909 lot: 60544935.Humeral stem 14 mm stem diameter 130 mm stem length cat: 00434901413 lot: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.

Event Description

It was reported that the patient was revised due to superior malpositioning of the glenoid component that led to wear of the humeral component.It was further stated that the patient was noncompliant.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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

It was reported that the patient was revised due to aseptic loosening of the glenoid component.It was further stated that the patient was noncompliant.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the explanted glenosphere and baseplate, both showing signs of wear and damage from extensive use.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.It is alleged that the patient was a very active patient and the glenoid component was placed quite superiorly on the glenoid face with superior inclination, rather than inferiorly with inferior inclination.The effects of this were twofold.The superior position increased the risk of scapula notching, which would have explained the wear observed on the polyethelene where the poly had butted against the lateral border of the scapula.The superior inclination created a sheer force at the glenoid/implant interface rather than a compressive force, which would have predisposed the implant to micro-motion and compromised secondary fixation.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.H3 other text : product not returned.

Event Description

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

• Brand Name: UNKNOWN BEARING
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12461246
• MDR Text Key: 271070553
• Report Number: 0001822565-2021-02574
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130661
• 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,Followup
• Report Date: 02/08/2022

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 Catalogue Number: 00434903611
• Device Lot Number: 60741589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 01/11/2022; 02/07/2022
• Supplement Dates FDA Received: 02/04/2022; 02/08/2022
• 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
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male