MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM VIT E LINER +0MM; SHOULDER, PROSTHESIS

Model Number 00-4350-036-00

Device Problem Difficult to Insert (1316)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/05/2023

Event Type  Injury  

Manufacturer Narrative

(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01762, 0001822565-2023-01764 d10: 36mm vit e liner +0mm cat: 00435003600 lot: 65585396 14mm ã¿ 130mm length humeral stem cat: 00434901413 lot: 65840581 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.

Event Description

It was reported that the tm reverse poly did not impact onto stem.Subsequently, a humeral fracture occurred due to this issue.The poly was impacted onto the stem on the back table then re-implanted.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The reported event is not confirmed.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: 36MM VIT E LINER +0MM
• 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: 17248656
• MDR Text Key: 318344401
• Report Number: 0001822565-2023-01761
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024269392
• UDI-Public: (01)00889024269392(17)271031(10)65532361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133378
• 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: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-4350-036-00
• Device Catalogue Number: 00435003600
• Device Lot Number: 65532361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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): Other
• Patient Sex: Female