MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER KINECTIV MODULAR NECK; HIP PROSTHESIS

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Fatigue (1849); Pain (1994); Reaction (2414)

Event Date 09/25/2013

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Concomitant medical products: item #00625006525, self-tapping bone screw, lot #61185889; item #00620205422, porous shell with cluster holes, lot #61132712; item #00630505036, polyethylene liner, lot #61193853; item #00625006520, self-tapping bone screw, lot #61180970.

Event Description

Legal counsel for patient reported that patient underwent a left hip revision approximately four years post-implantation due to pain, fatigue, elevated cobalt levels, psuedotumor.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received in medical records indicates the patient was revised due to pain and elevated metal ion levels.Medical records further indicate an mri scan revealed fluid collection consistent with a pseudotumor, which is indicative of metal debris or synovitis.Revision operative report notes that during the procedure, a dark gray pseudocapsule containing rusty colored fluid was encountered and the acetabular liner was noted as discolored and worn.

Manufacturer Narrative

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

Manufacturer Narrative

Reported event was confirmed by review of medical records provided.Revision operative notes stated that upon entering the deep layers a gray yellow discolored pseudocapsule was immediately identified.The capsule also had brownish staining throughout.When pseudocapsule was opened, a moderate amount of clear rust colored fluid expressed under tension.Cultures were taken for anaerobic and aerobic culture and sensitiveness and gram stain.Inspection of acetabular component revealed moderate wear.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined.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 was reported patient had a revision procedure four years post-implantation due to elevated ion levels.Operative notes noted a gray-yellow discolored pseudocapsule was identified.The capsule also had brownish staining.The pseudocapsule also had a moderate amount of clear rust-colored fluid expressed under tension.The acetabular component revealed moderate wear.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: ZIMMER KINECTIV MODULAR NECK
• 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: 6375617
• MDR Text Key: 68967047
• Report Number: 0001822565-2017-01386
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2018

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 Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00784802300
• Device Lot Number: 61040854
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: 11/28/2017; 02/26/2018
• Supplement Dates FDA Received: 12/28/2017; 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2008
• 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: 64 YR
• Patient Weight: 75