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

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Reaction (2414)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.The product identification necessary to review device history records was not provided.Concomitant product(s): liner standard/ pn 00630505840/ ln unknown.This report is number 2 of 2 mdrs filed for the same event.(reference 0001822565-2017-00295).The following sections could not be completed with the limited information provided.Device product code - ni.Expiration date - ni.Unique identifier (udi) # - ni.Manufacture date ¿ ni.

Event Description

Patient's right knee was revised approximately 3 years post-implantation due to metallosis, adverse local tissue reaction (altr) and pseudotumor.During the procedure, corrosion was noted at the junction of the femoral head and neck of the stem.The femoral head and acetabular liner were removed and replaced.

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.Photo of the stem shows dark debris on the neck of the stem.Device history record 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.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 receipt of information received and reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN ML 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: 6306852
• MDR Text Key: 66674248
• Report Number: 0001822565-2017-00379
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• 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: 04/03/2018

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: 12/05/2017; 03/05/2018
• Supplement Dates FDA Received: 12/06/2017; 04/04/2018
• 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: 67 YR
• Patient Weight: 93