MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD SSK 360 FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Crack (1135); Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product location unknown.

Event Description

It was reported that the sterile packaging was found cracked.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies relevant to the reported event were found.The reported event has been addressed as part of previous investigations after complaints were received reporting that the blisters were cracking.It was determined that thin/variable blister wall thickness and no head-space in the shelf carton were causing the blister to deform and crack during distribution.The packaging design configuration was changed to address this issue.Therefore, the root cause is related to design deficiency.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: VANGUARD SSK 360 FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7342583
• MDR Text Key: 102598370
• Report Number: 0001825034-2018-01898
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: PK093293
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 185282
• Device Lot Number: 3852857
• Other Device ID Number: 00880304482043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Date Manufacturer Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1