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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF TWIN-PEG CMNTD FEM LG PMA; PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. OXF TWIN-PEG CMNTD FEM LG PMA; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Date 08/05/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Please see associated reports: 0001825034 - 2018 - 01434, 0001825034 - 2018 - 01435.This report is being submitted late as it has been identified in remediation.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Device remains implanted.
 
Event Description
It was reported in clinical study 453 one patient underwent right knee surgery on (b)(6) 2014.Subsequently, post-operative pain and other experiences were reported at the follow up visits: post op visit eq5d - some problems walking, unable to perform usual activities, moderate pain and oxford - moderate pain, troubled by pain in bed most nights, pain has moderately interfered with usual work, and moderately difficult to go down stairs.1 year - eq5d - some problems walking, moderate pain; oxford - often limping, moderately difficult to kneel, and troubled in bed by pain most nights.At this time there is no indication of surgical delays or medical intervention.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 3002806535 - 2018 - 00531.
 
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Brand Name
OXF TWIN-PEG CMNTD FEM LG PMA
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7335941
MDR Text Key102300997
Report Number0001825034-2018-01433
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date03/31/2024
Device Model NumberN/A
Device Catalogue Number161470
Device Lot Number317380
Other Device ID Number(01) 05019279438259
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/06/2014
Initial Date FDA Received03/13/2018
Supplement Dates Manufacturer Received03/20/2018
Supplement Dates FDA Received03/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2014
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age49 YR
Patient Weight83
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