MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD XP 4IN1 CUT BLOCK ACL PROTECTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem Arthritis (1723)

Event Date 05/20/2013

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Medical product- vanguard xp interlock femoral component catalog# 195203 lot# 822670; vanguard xp tibial tray catalog# 195246 lot# 833150; vanguard xp tibial bearing rm catalog# 195397 lot# 883620; vanguard tibial bearing rl catalog# 195327 lot# 908020; biomet series a thin patella catalog# 184784 lot# 976820 the instrument was not returned for evaluation due to unknown location.Review of the device history record (dhr) was not performed due to unknown lot number provided.Review of the complaint history identified four additional complaints associated with the part (catalog) number.Without an opportunity to examine the instrument, the root cause could not be determined and the event could not be confirmed.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, "incorrect assemble of/to mating instruments¿.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.This report is being submitted late as it has been identified in remediation.

Event Description

Information was received based on review of "gk9c vanguard xp early clinical evaluation clinical study (b)(6)" a patient was identified in the study that underwent right knee surgery on (b)(6) 2013 for the primary diagnosis of osteoarthritis.It was reported that the acl protector did not adequately assemble to and disassemble from the 4 in 1 cutting block.The reason provided is unclear (we couldn't use bone was in at didu/out).It was noted that even though the acl protector was not used, the acl was fine.At this time the patient outcome is unknown and there is no indication of surgical delays or medical intervention.Attempts have been made and no further information has been provided.

• Brand Name: VANGUARD XP 4IN1 CUT BLOCK ACL PROTECTOR
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 7061214
• MDR Text Key: 93610825
• Report Number: 0001825034-2017-10388
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 32-700370
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 54