MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK PLASMA SPRAYED SIZE 7.5; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Information (3190)

Event Date 01/28/2021

Event Type  malfunction  

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.

Event Description

It was reported the implant was contaminated upon opening interior package.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by visual examination of the device.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to transit damage.The likely condition of the part when it left zimmer biomet control is considered conforming based on the evaluation of the returned product, the dhr review, and the potential transit age of the device (over 7 years).Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided.

• Brand Name: FEMORAL STEM 12/14 NECK PLASMA SPRAYED SIZE 7.5
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11280655
• MDR Text Key: 230457432
• Report Number: 0001822565-2021-00266
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

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 Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00771100740
• Device Lot Number: 62478896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1