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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL-POLY PATELLA CEMENTED 35 MM DIAMETER PROSTHESIS, KNEE

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ZIMMER MANUFACTURING B.V. ALL-POLY PATELLA CEMENTED 35 MM DIAMETER PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Scar Tissue (2060); Swelling (2091)
Event Date 07/31/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant associated products : item#:42522400711; articular surface fixed bearing posterior stabilized (ps); lot#:63749858. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded. 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: 3007963827 - 2020 - 00220.

 
Event Description

It was reported the patient underwent right total knee arthroplasty approximately 3 years ago. The patient later experienced pain and swelling. The patient was thought to have a loose patellar component and was suspicious for infection. Upon revision on two months ago, the patellar component was not grossly loose, and signs of infection were not noted. Scar tissue was encountered and removed. The patella and liner were replaced.

 
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Brand NameALL-POLY PATELLA CEMENTED 35 MM DIAMETER
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10522070
MDR Text Key206541781
Report Number0002648920-2020-00405
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42540200035
Device LOT Number63604776
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/25/2017
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: 09/11/2020 Patient Sequence Number: 1
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