MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY MODULAR FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Host-Tissue Reaction (1297)

Event Date 07/11/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Concomitant medical products: versys hip system femoral head , p/n 00801803602; kinectiv technology modular neck g, p/n 00784802300; zimmer m/l taper hip prosthesis with kinectiv technology modular femoral stem, p/n 00771301000; trident cluster acetabular shell p/n 542-11-54f; trident x3 0 polyethylene insert p/n 623-00-36f.Multiple mdr reports were filed for this event.Please see associated reports: 0001822565-2017-03760, 0001822565-2017-03761 and 0001822565-2017-03762.

Event Description

It was reported that patient underwent a revision procedure five years post-implantation due to implant corrosion and adverse local tissue reaction with a pseudotumor and trunionnosis.Operative notes report the patient had corrosion between the neck and the head.A large amount of blackened tissue surrounding the taper junction on the trunnion was identified.Furthermore, corrosion products were identified within the taper junction of the femoral head itself.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no were trends identified.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

This report is being submitted to relay additional information.Upon receipt of additional information of the reported event, it was determined that this device is not reportable as it was not involved in the event and did not malfunction.This report should be voided.

• Brand Name: ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY MODULAR FEMORAL STEM
• Type of Device: PROSTHESIS, HIP
• 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: 6604024
• MDR Text Key: 76377205
• Report Number: 0001822565-2017-03762
• Device Sequence Number: 1
• Product Code: KWA
• 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,Followup
• Report Date: 06/14/2018

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
• Device Catalogue Number: 00771301000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 11/03/2017; 05/22/2018
• Supplement Dates FDA Received: 11/03/2017; 06/14/2018
• 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