MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X25MM ST/RST; PROSTHESIS, SHOULDER

Catalog Number 115395

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 as reported that the inner package was open compromising the sterility.No adverse consequences for the patient or surgical delay.No further information has been made available at this time.

Manufacturer Narrative

No product was returned or photographs were provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no related deviations or anomalies.Root cause is undetermined.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 available at the time of this reporting.

• Brand Name: COMP RVS CNTRL 6.5X25MM ST/RST
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8503404
• MDR Text Key: 141587820
• Report Number: 0001825034-2019-01672
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304677074
• UDI-Public: 00880304677074
• Combination Product (y/n): N
• PMA/PMN Number: NOT RELEASED
• 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: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115395
• Device Lot Number: 157620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 80 YR