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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE ULTRACONGRUENT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE ULTRACONGRUENT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Unstable (1667); Naturally Worn (2988)
Patient Problems Damage to Ligament(s) (1952); Pain (1994); Swelling (2091)
Event Date 12/16/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 00542000800 ¿ patella ¿ 61621399; 00541401401 ¿ femoral component ¿ 61789863; 642000100 ¿ tibial tray ¿ 61493582. Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2019 -01542, 0001822565 -2019 -01543, 0001822565 -2019 -01544.

 
Event Description

It was reported that the patient underwent left knee revision approximately 5 years post implantation due to pain, swelling, stiffness, instability, ligament laxity, and poly wear and fracture. During the revision procedure, cysts were also noted around the tibial plateau.

 
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Brand NameARTICULAR SURFACE ULTRACONGRUENT
Type of DevicePROSTHESIS, 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 Key8524264
MDR Text Key142260023
Report Number0001822565-2019-01540
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK173057
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2019
Device MODEL NumberN/A
Device Catalogue Number00542801009
Device LOT Number61136943
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/29/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/14/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/19/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/17/2019 Patient Sequence Number: 1
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