MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD XP TIBIAL BEARING-LEFT MEDIAL PROSTHESIS,KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Claudication (2550)

Event Date 06/26/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: vanguard xp femoral interlok with pegs, catalog#: 195214, lot#: 990240. Vanguard xp tibial tray-interlok, catalog#: 195248, lot#: 752560. Vanguard xp tibial bearing-left lateral, catalog#: 195367, lot#: 677800. The device was not returned for evaluation due to unknown location. Review of the device history record (dhr) found no deviations or anomalies. Review of complaint history for same or similar issue identified five additional complaints for part (item) number and two additional complaints were identified for part/lot combination. Without the opportunity to evaluate the device, the complaint was not confirmed and root cause could not be determined. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. Associated risk table lists "miscellaneous user needs (general post-operative pain )¿. Following review, no new risks were identified. 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: 0001825034-2018-01255/01256/01258. This report is being submitted late as it has been identified in remediation.

Event Description

It was reported as part of a clinical study that a patient underwent a left knee procedure on (b)(6) 2014. Subsequently, the patient reported moderate pain, problems with walking and performing daily activities, often limping, and difficulty using stairs during the six (6) month, one (1) and two (2) year follow up visits. It was also reported that the patient was still using a cane 2 years post implant. Attempts have been made and no further information has been provided.

• Brand Name: VANGUARD XP TIBIAL BEARING-LEFT MEDIAL
• Type of Device: PROSTHESIS,KNEE
• 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: 7288835
• Report Number: 0001825034-2018-01259
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK122160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 195437
• Device Lot Number: 825590
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2013
• 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 Age: 70 YR
• Patient Weight: 70
• Patient Outcome(s): Other; Required Intervention