MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER M/L TAPER STEM; HIP PROSTHESIS

Model Number N/A

Device Problem Corroded (1131)

Patient Problem No Code Available (3191)

Event Date 07/20/2015

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Concomitant medical products: item #unk, trilogy spiked cup, lot #unk; item #unk, unknown liner, lot #unk.

Event Description

Legal counsel for patient reported that patient underwent a initial hip procedure and subsequently patient was revised due to corrosion.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products - unknown trilogy cup; unknown ml taper kinnectiv neck; unknown biolox head; unknown liner.Complaint operative notes were evaluated and the reported event was able to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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 continue to monitor for trends.

Event Description

Legal counsel for patient reported that patient underwent a initial hip procedure and subsequently patient was revised due to corrosion and pain.Revision operative record noted osteolysis around the acetabulum, moderate corrosion on the femoral stem and neck as well as some metal staining around the neck.All components were removed and replaced.No further information available.

• Brand Name: UNKNOWN ZIMMER M/L 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: 6375615
• MDR Text Key: 68966872
• Report Number: 0001822565-2017-01220
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2017
• 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: 68 YR