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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 Hematoma (1884); Impaired Healing (2378)
Event Date 08/23/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: associated products : 42502606802, femur cemented cruciate retaining (cr) standard right size 10, 64148718; 42532007902, tibia cemented 5 degree stemmed right size g, 64251064; 42521000610, articular surface fixed bearing cruciate retaining (cr) right 10 mm height, 64335177. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00264, 3007963827-2019-00265, 3007963827-2019-00266.

 
Event Description

It was reported patient underwent an i&d approximately 3 weeks post implantation due to a hematoma and delayed primary closure.

 
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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 Key9075162
MDR Text Key158787471
Report Number0002648920-2019-00687
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,Followup
Report Date 03/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42540000035
Device LOT Number64325377
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 Received03/19/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/06/2019
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: 09/17/2019 Patient Sequence Number: 1
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