MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BF PEGGED GLENOID 46MM; PROSTHESIS, EXTREMITY

Catalog Number 00430008600

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00-4302-046-19, lot 62694514, bf offset hum head 19mm x 46mm; 00-4300-012-13, lot 63801971, bf humeral stem 12mm x 130mm; 00-1109-015-00, lot 62523023, zimmer poly-plug medullary plug, 15mm.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient had first stage revision in a two stage operation to address infection.No further information is available at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr 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.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 information is available at this time.

• Brand Name: BF PEGGED GLENOID 46MM
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8403491
• MDR Text Key: 138222823
• Report Number: 0001822565-2019-01026
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00430008600
• Device Lot Number: 63811744
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention