MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MD HYBRID GLENOID BASE 4MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abscess (1690)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2018 - 11401, 0001825034 - 2018 - 11402, 0001825034 - 2018 - 11403, 0001825034 - 2018 - 11404.(b)(4).Concomitant medical products: 115740 compr nano hmrl pps 40mm lot 820550, 118001 versa-dial/comp ti std taper lot 260450, 113042 versa-dial 46x18x53 hum head lot 060280, 113954 md hybrid glenoid base 4mm lot 268280, pt-113950 pt hybrid glen post regenerex lot 742260.Foreign- the event occurred in (b)(6).As the devices remain implanted; they will not be returned for evaluation.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 a suture abscess that required an irrigation and debridement as well as oral antibiotics; procedure related but not device related, approximately six (6) weeks post-operatively of a total shoulder arthroplasty.No further information is available.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed from review of operative notes.Review of sterilization certification confirms devices were sterilized in accordance with device specifications.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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: MD HYBRID GLENOID BASE 4MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8237125
• MDR Text Key: 132775926
• Report Number: 0001825034-2018-11403
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K060694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2022
• Device Model Number: N/A
• Device Catalogue Number: 113954
• Device Lot Number: 268280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2019
• 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
• Patient Age: 75 YR
• Patient Weight: 76