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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Rash (2033); Reaction (2414)

Event Date 06/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Current information is insufficient to permit a conclusion to the cause of the event.(b)(4).

Event Description

Patient reported metallosis diagnosis and is experiencing severe swelling along with rash/bumps all over leg.No hip revision has been reported to date.

Manufacturer Narrative

This follow up report is being filed to relay updated and additional information.Updated: additional: reported event was unable to be confirmed.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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.Multiple mdr reports were filed for this event, please see associated report(s): 0001822565-2017-01683-1, 0001822565-2017-01684-1.

• Brand Name: MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS
• 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: 6414920
• MDR Text Key: 70298395
• Report Number: 0001822565-2017-01684
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00771301100
• Device Lot Number: 63239650
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: 02/16/2017
• Supplement Dates FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2016
• 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
• Patient Age: 60 YR