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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 8 PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 8 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Unintended Movement (3026)
Patient Problems Pain (1994); Tissue Damage (2104)
Event Date 01/30/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: associated products: item#:42540000035; all poly patella cemented 35 mm diameter; lot#:64189156. Item#:42530007902;natural tibia trabecular metal two-peg porous fixed bearing right size g; lot#:63905801. Item#:42522100912; articular surface medial congruent (mc) right 12 mm height use with tibia sizes g-h/cr femur sizes 8-11; lot#:64167122. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted. 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: 0002648920-2020-00175.

 
Event Description

It was reported that the patient underwent an initial total right knee arthroplasty and subsequently, he experienced right knee patellar clunk and received an intraarticular corticosteroid injection approximately one year later.

 
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Brand NameFEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 8
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 Key9834867
MDR Text Key183502971
Report Number3007963827-2020-00080
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 06/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42502606402
Device LOT Number63964229
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 Received06/12/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2018
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: 03/16/2020 Patient Sequence Number: 1
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