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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Sherman, k.; goodfellow, j.; tibrewal, s.; o¿connor, j.(1985) bilateral oxford meniscal knee arthroplasty.Journal of the royal society of medicine volume 78 november 1985, 916-919.Product was not returned to zimmer biomet for investigation.Without the opportunity to examine the complaint product, root cause cannot be determined.Without the opportunity to examine the complaint product, root cause cannot be determined.Part and lot identification are necessary for review of manufacturing records, deviation history, and complaint history, neither were 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.(b)(4).

Event Description

It was reported one patient was identified in the article who underwent arthrodesis due to infection following knee arthroplasty on unknown date.There has been no further information provided and the patient outcome is unknown.All other events will be reported in individual records which will be linked to this parent record.

• Brand Name: UNKNOWN KNEE
• 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: 6936149
• MDR Text Key: 89087169
• Report Number: 0001825034-2017-08336
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN KNEE
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2015
• Initial Date FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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