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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 9 PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 9 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscular Rigidity (1968); Scar Tissue (2060); Limited Mobility Of The Implanted Joint (2671)
Event Date 05/19/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated report: 3007963827-2020-00145, 3007963827-2020-00146. Concomitant medical products: tibia cemented 5 degree stemmed right size g, item# 42532007902, lot# 64403058. Articular surface fixed bearing cruciate retaining (cr) right 12 mm height, item# 42521000612, lot# 64401203. Report source - (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that a patient underwent manipulation under anesthesia due to stiffness approximately two months and one-week post implantation. There is no additional information at this time.

 
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Brand NameFEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 9
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10106540
MDR Text Key193121117
Report Number3007963827-2020-00144
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeNO
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42502606602
Device LOT Number64595673
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 Received09/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/02/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 06/01/2020 Patient Sequence Number: 1
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