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

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi)# : n/a.

Event Description

It was reported that a hair was found inside the sterile package.No adverse events to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product identified hair-like debris within the sealed sterile pouch.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the product when leaving zimmer biomet was not conforming to specifications.The root cause of the reported issue is attributed to operator error during the manufacturing process.Corrective action has been initiated.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.Unique identifier (udi) #: (b)(4).

Event Description

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

• Brand Name: LG 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: 8354291
• MDR Text Key: 136766808
• Report Number: 0001825034-2019-00673
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2023
• Device Model Number: N/A
• Device Catalogue Number: 113956
• Device Lot Number: 661260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1