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

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Date 01/30/2014

Event Type  Injury  

Event Description

It is reported that a patient was revised due to stem loosening.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products- unknown liner, unknown shell, unknown head.Reported event was confirmed through review of medical records.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.There are warnings in the package insert that this type of event can occur and associated risks are addressed in risk documentation.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 medical records indicates the patient was revised due to loosening of the femoral stem.During the procedure, the stem was found grossly loose; however, the cement mantle was intact.The femoral stem, femoral head and acetabular liner were removed and replaced.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.The information contained within this report does not alter previous investigation conclusions.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.

• Brand Name: UNKNOWN ZIMMER 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: 6142632
• MDR Text Key: 61395840
• Report Number: 0001822565-2016-04477
• 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: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2017

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: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: 09/06/2017; 09/14/2017
• Supplement Dates FDA Received: 09/14/2017; 09/20/2017
• 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; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 78