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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR STANDARD RIGHT SIZE 9 PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR 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 Wound Dehiscence (1154); Impaired Healing (2378)
Event Date 12/10/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). Item # 42532007502 lot # 63078128, item # 42521000510 lot # 62846474, item # 42540000032 lot # 63104082. Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00454, 0002648920-2019-00455, 0002648920-2019-00479. Reported event was confirmed by review of medical records. Medical records were provided and reviewed by a health care professional. Review of the available records identified the following: primary surgical note was provided and found no complication. The office visit notes states that there is a delay in the healing wound. Device history record was reviewed and no discrepancies were found. No product was returned; visual and dimensional evaluations could not be performed. A definitive root cause cannot be determined. Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
Event Description

It was reported that approximately one month post implantation, a patient required medical treatment due to delayed wound healing. The patient was treated with wet to dry wound dressings during a post operative office visit. Attempts have been made and no further information has been provided.

 
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Brand NamePERSONA FEMUR 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 Key8739021
MDR Text Key149334251
Report Number3007963827-2019-00196
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42502606602
Device LOT Number62945429
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 Received09/18/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/19/2015
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: 06/27/2019 Patient Sequence Number: 1
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