MAUDE Adverse Event Report: ZIMMER, INC. - BUILDING 5 UNKNOWN ZIMMER HEAD; KWZ

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is scheduled to be revised due to pain, head migration and polyethylene wear.

Manufacturer Narrative

No devices or photos were received, therefore the condition of the devices is unknown.The lot numbers of the products are unknown, therefore the device history records and complaint history could not be reviewed.These devices are used for treatment.It could not be confirmed if the devices were used in an approved and compatible combination.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Relevant medical history and adherence to rehabilitation protocol are unknown.A definitive root cause cannot be determined with the information provided.

Manufacturer Narrative

Upon receipt of the product information on feb 24, 2017 the femoral component was identified as being manufactured at the zimmer biomet manufacturing facility in (b)(4), and not in (b)(4) as documented in the intial report 0001822565-2016-01246.The proper reporting of this event can be found in report 3007963827 - 2017 - 00033.

• Brand Name: UNKNOWN ZIMMER HEAD
• Type of Device: KWZ
• Manufacturer (Section D): ZIMMER, INC. - BUILDING 5; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC. - BUILDING 5; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5597599
• MDR Text Key: 43315231
• Report Number: 1822565-2016-01246
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2017

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
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/05/2016; 03/24/2017
• 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): Other