MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ZIMMER TRILOGY LINER; HIP PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Reaction (2414)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It was reported that the patient was revised due to pain.The patient also had cobalt chromium shavings in the associated tissue and muscle causing muscle deterioration.

Manufacturer Narrative

Upon receipt of additional information the manufacturer location has changed.Reference mfg # 0002648920-2016-03295.

• Brand Name: UNKNOWN ZIMMER TRILOGY LINER
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 5441767
• MDR Text Key: 38354996
• Report Number: 1822565-2016-00304
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2017

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: 01/20/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/15/2017; 03/17/2017
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 91