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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 38 MM DIAMETER PROSTHESIS, KNEE

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ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 38 MM DIAMETER PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolism (1829)
Event Date 07/31/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Associated products : item#:42500607002; femur cemented posterior stabilized ; lot#:64492536. Item#:00596204210; articular surface; lot#:63778489. Item#:00598004702; stemmed tibial component precoat size 6; lot#:j6767119. 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: 3007963827 - 2020 - 00219. 0001822565 - 2020 - 03190. 0001822565 - 2020 - 03191.

 
Event Description

It was reported that patient underwent right unilateral knee arthroplasty approximately 2 months ago. Subsequently, the patient began experiencing calf pain and swelling. The patient was seen one week post-op for ultrasound which identified a dvt. Patient prescribed xarelto. Outcome pending.

 
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Brand NameALL POLY PATELLA CEMENTED 38 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 Key10510999
MDR Text Key206302511
Report Number0002648920-2020-00403
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 Received09/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42540000038
Device LOT Number64621052
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 Manufactured01/16/2020
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: 09/09/2020 Patient Sequence Number: 1
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