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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 04/18/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a revision procedure due to implant loosening and fractured screws.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Medical products: unknown vrs cat#ni lot#ni; unknown central screw cat#ni lot#ni; unknown peripheral screw cat#ni lot#ni; unknown peripheral screw cat#ni lot#ni; unknown peripheral screw cat#ni lot#ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01624, 0001825034-2022-01625, 0001825034-2022-01626, 0001825034-2022-01627 and 0001825034-2022-01628.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant products the unknown vrs is updated to: compr vrs glen pps min tpr adr cat#110027734 lot# 811810.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided for the screws.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a reverse-type left shoulder arthroplasty is present.Several of the glenoid fixation screws are fractured and there is suspected glenoid implant loosening.No osseous fracture is identified.There is no dislocation.It was alleged that the patient was noncompliant; however without additional information on the noncompliance or medical records to confirm the allegation, 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.

• Brand Name: UNKNOWN PERIPHERAL SCREW
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15013821
• MDR Text Key: 295873576
• Report Number: 0001825034-2022-01629
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 84 KG