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

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It was reported that a male patient was experiencing pain and limited mobility.The patient underwent revision due to loosening of acetabular components, the acetabular cup migrated and the patient presented with elevated metal ions.The patient had mild heterotopic ossificatioin at the tip of the greater trochanter and test results indicate there was some mild chronic inflammation.

Manufacturer Narrative

Reported event was confirmed through review of medical records.Device history record and complaint history were not reviewed as the product identification is unknown.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined with the information available.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

Additional information received in revision operative report indicates the patient had some shortening of the right lower extremity compared to the left, which was corrected during the revision procedure.Discolored, yellow-green tinted and thick fluid were noted within the joint, as was gross loosening of the acetabular component.No corrosive changes or component failure indicated during inspection of the modular neck; however, erosive changes were noted in the posterior calcar region.Tests performed on the fluid within the joint were negative for infection.The acetabular cup and head were removed and replaced.

• Brand Name: UNKNOWN ZIMMER KINECTIV 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5829112
• MDR Text Key: 50641301
• Report Number: 0001822565-2016-02605
• 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: 08/23/2017

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 08/23/2017
• 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; Other; Required Intervention
• Patient Age: 48 YR