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

Model Number N/A

Device Problem Corroded (1131)

Patient Problem No Information (3190)

Event Date 06/11/2015

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Concomitant medical products - femoral head/ pn 00801803201/ ln 61676485, 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: 0001822565-2017-03288.

Event Description

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

Manufacturer Narrative

Device was not returned so no product evaluation could be conducted.This device was used for treatment.Device history records were reviewed and no related discrepancies were found.Review of the complaint histories determined that no further action is required as no were trends identified.Root cause was unable to be determined.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.

Manufacturer Narrative

Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001822565-2019-01975.

Event Description

Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001822565-2019-01975.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER STEM
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6583149
• MDR Text Key: 75703540
• Report Number: 0001822565-2017-03289
• 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,Followup
• Report Date: 08/14/2019

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: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00771101220
• Device Lot Number: 61548754
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2010
• 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