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

Model Number N/A

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Pain (1994); Numbness (2415); Ambulation Difficulties (2544)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes and x-rays.Operative notes provided from a pre-revision office visit state that patient had been experiencing symptoms of pain, grinding, popping, instability and difficulty ambulating for approximately 8 months.Review of pre-revision x-rays show mild lateral asymmetric position of the prosthetic femoral head consistent with poly liner wear.There was slightly asymmetric lucency within the acetabulum and along gruen zones 1 and 7 of the femoral component.There was no evidence of component loosening.Device history record (dhr) 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 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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2018 -00686, 0002648920 -2018 -00685, 0001822565 -2018 -05318.

Event Description

It was reported patient presented to physicians office approximately 22 years post implantation due to pain, grinding, popping/clicking, instability, numbness, and use of cane when walking.It was also noted that the left leg was longer than the right along with anterior and posterior impingement.Patient was scheduled for revision 2 months later where the head and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN TRILOGY CUP
• Type of Device: PROSTHESIS, HIP
• 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: 7914073
• MDR Text Key: 121870198
• Report Number: 0001822565-2018-05317
• Device Sequence Number: 1
• Product Code: JDG
• 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: Physician
• Type of Report: Initial
• Report Date: 09/27/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 09/27/2018
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 85