MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 65 D RET 36MM VIT E LNR +0MM; SHOULDER, PROSTHESIS

Catalog Number 00435006500

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure due to dislocation approximately four years post implantation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2023 -02154.D10: comp rvrs shldr glnsp std 36mm cat: 115310 lot: j7571012.25mm versa-dial taper adaptor cat: 118000 lot: j7500817.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was further reported that the patient was revised due to disassociation.

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.A review of the device history record(s) identified no deviations or anomalies during manufacturing.Further information received indicates that the patient was revised due to disassociation.Therefore, this product did not cause or contribute to the reported event and should be considered not reportable.The event is addressed on 0001825034-2023-02154.The reported event is unconfirmed.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: 65 D RET 36MM VIT E LNR +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: 17731119
• MDR Text Key: 323208058
• Report Number: 0001822565-2023-02492
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024269453
• UDI-Public: (01)00889024269453(17)270803(10)65439033
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130661
• 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: 12/14/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00435006500
• Device Lot Number: 65439033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention