MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FEM STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the procedure the doctor opened the package and noticed that there was a sticker sticking on m/l kinectiv stem.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Complaint was confirmed with a photograph of the product.Visual review identified the following: there was a sticker on the m/l taper stem.No further evaluation is possible using the photograph provided.Review of the device history records and packaging set up sheet identified no deviations or anomalies during manufacturing.The root cause can be attributed to manufacturing deficiency.A pqs-bwar-20-0328 was assigned for 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: MODULAR FEM STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10712993
• MDR Text Key: 212382096
• Report Number: 0001822565-2020-03591
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024132603
• UDI-Public: (01)00889024132603
• Combination Product (y/n): N
• PMA/PMN Number: K182678
• 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: 03/05/2021

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: 00771300600
• Device Lot Number: 64602696
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1