MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BEARING +3 MM RETENTIVE THICKNESS 36 MM DIAMETER; SHOULDER, PROSTHESIS

Model Number 2357-04-16

Device Problem Naturally Worn (2988)

Patient Problem Fall (1848)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: comp lk scr 3.5hex 4.75x30 st cat: 180553 lot: 791810.Comp rvrs shldr glnsp std 36mm cat: 115310 lot: 662660.Comp rvrs 25mm bsplt ha+adptr cat: 010000589 lot: 564600.Comp rvs cntrl 6.5x30mm st/rst cat: 115396 lot: 100840.Comp lk scr 3.5hex 4.75x25 st cat: 180552 lot: 792150.Comp primary stem 9mm mini cat: 113629 lot: 170250.Bearing standard 36 mm diameter cat: 110031424 lot: 64510457.Mini tray std cocr +3 offset cat: 110031402 lot: 64512179.25mm versa-dial taper adaptor cat: 118000 lot: 741600.Comp rvrs 25mm bsplt ha+adptr cat: 010000589 lot: 564600.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01300 and 0001825034-2023-01301.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 fell and the glenosphere was dislocated.The bearing was found to be worn.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.It was reported that a patient fell causing disassociation between the taper adapter and the baseplate.After the fall and before the revision occurred, the baseplate was wearing on the poly which caused an abnormal wear pattern.The baseplate wore down to the humeral tray leading to metal-on-metal wear.Debris of the metal on metal wear is present on the poly.The complications were indicated as being the result of the fall with no concerns or allegations prior.As this is an upper extremity implant, it would not have caused/contributed to the fall and subsequent complications.Upon reassessment of the reported event based on additional information, this product did not cause or contribute to the reported event.The initial report submitted needs to be voided.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BEARING +3 MM RETENTIVE THICKNESS 36 MM DIAMETER
• Type of Device: SHOULDER, PROSTHESIS
• 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: 17086011
• MDR Text Key: 316856981
• Report Number: 0001822565-2023-01534
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00889024055537
• UDI-Public: (01)00889024055537(17)240930(10)64465284
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181611
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2357-04-16
• Device Catalogue Number: 110031426
• Device Lot Number: 64465284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2019
• 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 Sex: Female