MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER MODULAR M/L FEMORAL TAPER STEM WITH KENECTIV TECHNOLOGY; HIP PROSTHESIS

Model Number N/A

Device Problem Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 10/18/2016

Event Type  Injury  

Manufacturer Narrative

Information was received from a foreign source who is not required to complete form 3500a.

Event Description

It was reported the inner plastic bag of the product turned black.The product was used by the surgeon.

Manufacturer Narrative

Upon further review it was found that this malfunction did not and has not been previously reported as causing or contributing to an adverse event.Therefore, the initial report was filed in error and should be voided.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: ZIMMER MODULAR M/L FEMORAL TAPER STEM WITH KENECTIV TECHNOLOGY
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6110665
• MDR Text Key: 60254853
• Report Number: 0001822565-2016-04262
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK032726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00771301600
• Device Lot Number: 62521427
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: 03/06/2018
• Supplement Dates FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other