MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZIMMER TRILOGY LONGEVITY LINER; HIP PROSTHESIS

Model Number N/A

Device Problems Corroded (1131); Unstable (1667)

Patient Problems Necrosis (1971); Pain (1994); Local Reaction (2035); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)

Event Date 07/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # unk, hip-versys-unknown-head, lot # unk.Item # unk, unk m/l kinectiv neck, lot # unk.Item # unk, hip-m / l taper-stems-unk, lot # unk.Item # unk, hip-trilogy-unknown-cups, lot # unk.Multiple reports have been submitted for this event.Please see associated reports: 0001822565-2018-05665, 0001822565-2018-05555, 0002648920-2018-00722.

Event Description

It was reported that a patient underwent a revision surgery approximately 7 years post implantation due to allegations of metallosis, pain, instability, altr, trunnionosis, necrosis, and limited rom.Medical findings listed in legal document as follows: adverse local tissue reaction, left hip (cobalt metal reaction); alval (aseptic lymphocyte dominated vasculitis-associated lesion); trunnionosis with necrotic ¿dead¿ periarticular muscle; metal disease; corrosion found at trunnion of 36 mm femoral head with titanium dual modular neck; and, abnormal colored tissue with avascularity.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device was originally reported under an incorrect manufacturing facility.The initial report was forwarded in error and should be voided.This device has been correctly reported under 0002648920 - 2018 - 00828.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN ZIMMER TRILOGY LONGEVITY LINER
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7959042
• MDR Text Key: 123489532
• Report Number: 0001822565-2018-05665
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2018
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention