MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER FEMORAL STEM; HIP PROSTHESIS

Device Problems Corroded (1131); Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient's hip arthroplasty was revised due to metallosis.

Manufacturer Narrative

Medical devices: femoral head sterile product do not resterilize 12/14 taper catalog# 00801804002 lot# 61697939; liner standard 3.5 mm offset 40 mm i.D.For use with 58 mm o.D.Shell catalog# 00630505840 lot# unknown.Reported event was confirmed by review of photos.The received photograph of the neck shows that there was mild fretting on the neck taper.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.

Event Description

It is reported that the patient's hip arthroplasty was revised due to metallosis.During the procedure liquefied tissue and corrosion of the neck/stem joint was identified.The femoral head and acetabular liner were removed and replaced.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Explant date is unknown.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: UNKNOWN ZIMMER FEMORAL STEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6080930
• MDR Text Key: 59264411
• Report Number: 0001822565-2016-04096
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 65 YR
• Patient Weight: 99