MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TRILOGY ACETABULAR SYSTEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

The complaint number corresponding to this medwatch is (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-02689, 0002648920-2017-00257, 0002648920-2017-00258, 0001822565-2017-02693 & 0001822565-2017-02694.

Event Description

It was reported that the patient's left hip was revised approximately three months post-implantation due to a deep infection, possible mrsa.All implants were removed and replaced with cement spacer molds.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.It was identified an internal software error produced and submitted an invalid device product code in the previous submissions related to this reporting.The device product code has been updated with no further changes.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

No further information available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: biolox⮠delta, ceramic femoral head, l, 㸠36/+3.5, taper 12/14 p/n 00877503603, l/n 2806905.Reported event was confirmed by review of provided office notes.Dhr was reviewed and no discrepancies were found.Sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards.Review of the complaint history determined that no further action is required.According to office visit notes the patient was diagnosed with an infection and inflammatory reaction due to the internal joint prosthesis and initial encounter.Methicillin-resistant staphylococcus aureus infection was identified at an unspecified site.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: TRILOGY ACETABULAR SYSTEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6521927
• MDR Text Key: 73706751
• Report Number: 0002648920-2017-00257
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006525
• Device Lot Number: 63526050
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2016
• 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: 70 YR