MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 11MM MINI; PROSTHESIS- KNEE

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2018-08613.(b)(4).Concomitant medical products: oss porous im stem 15.5 x 150 item# 150394 lot# 068390.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a shoulder stem was found packaged in an oss stem carton.No additional information is available at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The complaint sample was evaluated and the reported event was confirmed through visual inspection.The returned stems confirmed that the label on the box and item within the box were not identical.Dimensional analysis was also performed to confirm this discrepancy.Review of the device history records did not identify any discrepancies relevant to the reported event.As the event occurred during the manufacturing process, the root cause can be attributed to manufacturing deficiency.Corrective action has been taken to address the reported issue.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: COMP PRIMARY STEM 11MM MINI
• Type of Device: PROSTHESIS- KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7842969
• MDR Text Key: 119088129
• Report Number: 0001825034-2018-08614
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: PK060692
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113631
• Device Lot Number: 568150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1