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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of Range of Motion (2032); Scar Tissue (2060); Limited Mobility Of The Implanted Joint (2671)
Event Date 07/09/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00185, and 0002648920-2020-00362. Concomitant medical devices: femur cemented cruciate retaining (cr) standard left size 8 catalog#: 42502606401 lot#: 64439138, all poly patella cemented 38 mm diameter catalog#: 42540000038 lot#: 64580484, natural tibia cemented 5 degree stemmed left size e catalog#: 42532007101 lot#: 64459817. 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 patient underwent left knee manipulation under anesthesia approximately two months after initial implantation due to stiffness, difficulty ambulating, limited range of motion, and a diagnosis of arthrofibrosis. Attempts have been made and no further information has been provided.

 
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Brand NameARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT
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 Key10356047
MDR Text Key201361859
Report Number3007963827-2020-00186
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,STUDY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42512100812
Device LOT Number64419807
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 Received09/25/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/27/2019
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: 08/03/2020 Patient Sequence Number: 1
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