MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN KNEE; PROTHESIS KNEE

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Callahan, c., drake, b., heck, d., dittus, r.(1995) patient outcomes following unicompartmental or bicompartmental knee arthroplasty.The journal of arthroplasty , volume 10 , issue 2 , 141 - 150.Product not available for return.Without the opportunity to examine the complaint product, root cause cannot be determined.Due to a lack of part and lot numbers, manufacturing, deviation and complaint histories were unable to be located and assessed.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 a journal article entitled, "patient outcomes following unicompartmental or bicompartmental knee arthroplasty.A meta-analysis." the purpose of this study was to summarize the literature describing patient outcomes following unicompartmental and bicompartmental knee arthroplasty.This complaint addresses the, patient revisions due to mechanical failure, due to unknown reasons, on unknown dates.There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN KNEE
• Type of Device: PROTHESIS 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: 6965387
• MDR Text Key: 89845197
• Report Number: 0001825034-2017-09485
• Device Sequence Number: 1
• Product Code: NRA
• 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: literature,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2015
• 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): Required Intervention