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

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Lewold, s., goodman, s., knutson, k., robertson, o., and lidgren, l.(1995).Oxford meniscal bearing knee versus the marmor knee in unicompartmental arthroplasty for arthrosis.The journal of arthroplasty, 10(6), 722-731.Doi:10.1016/s0883-5403(05)80066-x.The product was not available for return.Without the opportunity to examine the complaint product, root cause cannot be determined.Part and lot identification are necessary for review of device history records and complaint history, neither were provided.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.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

Information was received based on review of a journal article entitled, "oxford meniscal bearing knee versus the marmor knee in unicompartmental arthroplasty for arthrosis.A swedish multicenter survival study" lewold, s.Et al.The journal of arthroplasty vol.10 no.6 1995.This complaint pertains to a patient who had a fourth reoperation following multiple closed reduction procedures.At this time, all components were removed and replaced with a total knee system.The date of the procedure is unknown.

• 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: 7045542
• MDR Text Key: 92516983
• Report Number: 0001825034-2017-10397
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/17/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2015
• Initial Date FDA Received: 11/20/2017
• 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