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

Model Number N/A

Device Problem Corroded (1131)

Patient Problem No Information (3190)

Event Date 11/01/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - femoral head/ pn 00801803202/ ln 61232607, unknown liner, unknown cup.Mw5068762 once the investigation has been completed, a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-03290.

Event Description

It was reported that a patient underwent a hip revision surgery approximately three years post implantation due to unknown reasons.It was noticed during the surgery that there was corrosion as well.There were no complications or delays reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined, as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will contribute to monitor for trends.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Type of Device: PROSTHESIS, HIP
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6583154
• MDR Text Key: 75703529
• Report Number: 0001822565-2017-03291
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00771100920
• Device Lot Number: 61006506
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2008
• 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): Hospitalization; Required Intervention