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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 5/6; PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 5/6; PROSTHESIS, ELBOW Back to Search Results
Catalog Number 00840009500
Device Problem No Apparent Adverse Event (3189)
Patient Problems Pain (1994); Peroneal Nerve Palsy (2362); Disability (2371)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdr's were reported for this event.Please also see associated reports: 0001822565 - 2019 - 01609, 0001822565 - 2019 - 01608, 0001822565 - 2019 - 01607, 0001822565 - 2019 - 01604.(b)(4).Concomitant medical products: part number: lot code: description: 00840004510 63287679 humeral stem, 00840009000 63610435 humeral screw, 00840001507 63175486 ulnar component, 00840009500 63570105 articulation kit.(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.
 
Event Description
It was reported the patient experienced severe pain and disability secondary to post operative radial nerve palsy.The event was reportedly not device related, but related to the surgical procedure.No further information is available at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No device was returned; the complaint cannot be confirmed.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause is unknown.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
No further information available at the time of this reporting.
 
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Brand Name
ARTICULATION KIT SIZE 5/6
Type of Device
PROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8523577
MDR Text Key142240345
Report Number0001822565-2019-01609
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
K123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Type of Report Initial,Followup
Report Date 07/31/2019
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 Health Professional
Device Expiration Date01/31/2022
Device Catalogue Number00840009500
Device Lot Number63570105
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/21/2019
Initial Date FDA Received04/17/2019
Supplement Dates Manufacturer Received07/23/2019
Supplement Dates FDA Received07/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age42 YR
Patient Weight73
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