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

Model Number N/A

Device Problems Corroded (1131); Metal Shedding Debris (1804)

Patient Problems Inflammation (1932); Necrosis (1971); Pain (1994); Fluid Discharge (2686)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown longevity acetabular liner; unknown versys femoral head; unknown kinectiv stem; unknown trilogy acetabular shell.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 medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 03409; 0001822565 - 2017 - 03415.

Event Description

It was reported patient¿s left hip was revised approximately 6 years post-implantation due to pain, pseudotumor, corrosion, dislocation, fluid collection, soft tissue with necrosis and chronic inflammation.Intraoperative findings stated failed left total hip arthroplasty with taper junction corrosion, pseudo tumor with completely absent gluteus medius and minimus attachments to the greater trochanter, evidence of corrosion and necrotic friable debris.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Reported event was unable to be confirmed.Device history record review was unable to be performed as the part number / 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

This follow-up is being submitted to relay additional information.Concomitant medical products -trilogy acetabular system longevity crosslinked polyethylene liner p/n 00630505036 l/n 61379632; versys hip system femoral head p/n 00801803602 l/n 61357236.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that this device was not involved in the event and should not have been reported.The initial report should be voided as it was submitted in error.

• Brand Name: ZIMMER M/L TAPER HIP PROSTHESIS 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: 6578909
• MDR Text Key: 75602480
• Report Number: 0001822565-2017-03416
• 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,Followup,Followup
• Report Date: 09/05/2017

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 Expiration Date: 12/02/2019
• Device Model Number: N/A
• Device Catalogue Number: 00771301000
• Device Lot Number: 61346509
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: Not provided; 08/01/2017; 09/05/2017
• Supplement Dates FDA Received: 06/28/2017; 08/29/2017; 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2009
• 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