MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source (b)(6).Product is in process of being returned to zimmer biomet for the investigation and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04146.

Event Description

It was reported that during incoming inspection, debris was found in the sterile packaging.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was returned and evaluated against the reported event.Visual inspection of the returned product identified that there is debris inside the sterile package.Dhr was reviewed and no discrepancies were found.The likely condition of the products when they left zimmer biomet was non-conforming.The root cause of the reported event is the operator not following instructions during the manufacturing process.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 additional event information to report at this time.

• Brand Name: TAPERLOC STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10868142
• MDR Text Key: 217134602
• Report Number: 0001825034-2020-04147
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K120030
• 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: 01/20/2021

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 Model Number: N/A
• Device Catalogue Number: 51-149050
• Device Lot Number: 6811462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1