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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKOWN LOCKING SCREW; IMPLANT, EXTREMETIES
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ZIMMER BIOMET, INC. UNKOWN LOCKING SCREW; IMPLANT, EXTREMETIES Back to Search Results
Catalog Number UNKNOWN LOCKING SCREW
Device Problems Fracture (1260); Unstable (1667); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Malunion of Bone (4529)
Event Date 06/09/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00599, 0001825034-2021-00616, 0001825034-2021-00617, 0001825034-2021-00619, 0001825034-2021-00620, 0001825034-2021-00621.Medical product: item#: unknown, unknown biomet alps small olecranon plate; lot#: unknown; item#: unknown, unknown locking screw; item#: unknown; item#: unknown, unknown locking screw; lot #: unknown; item#: unknown, unknown cortical screw; lot #: unknown; item#: unknown, unknown cortical screw; lot #: unknown; item#: unknown, unknown cortical screw; lot#: unknown.Customer has not indicated whether the product will be returned to zimmer biomet for investigation at this time, product location is unknown.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 patient underwent a right elbow o.R.I.F approximately one (1) yr and four (4) months ago.Patient's elbow was revised on an unknown date due to implant failure.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00599-1, 0001825034-2021-00616-1, 0001825034-2021-00617-1, 0001825034-2021-00619-1, 0001825034-2021-00620-1, 0001825034-2021-00621-1.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial elbow surgery occurred.Elbow revised on an unknown date due to implant failure.A definitive root cause could not be determined.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 event information available at the time of this report.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00599-2.0001825034-2021-00616-2.0001825034-2021-00617-2.0001825034-2021-00619-2.0001825034-2021-00620-2.0001825034-2021-00621-2.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 the patient underwent an initial right elbow o.R.I.F approximately one (1) year and six (6) months ago.The patient underwent a revision surgery approximately six (6) months after initial surgery due to pain, implant fracture and loosening.
 
Event Description
It was reported that the patient underwent an initial right elbow o.R.I.F approximately one (1) year and six (6) months ago.The patient underwent a revision surgery approximately six (6) months after initial surgery due to pain, loosening, implant fracture, decrease of activity of daily living, non-union/malunion, and instability.
 
Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00599-3 0001825034-2021-00616-3 0001825034-2021-00617-3 0001825034-2021-00619-3 0001825034-2021-00620-3 0001825034-2021-00621-3 the following sections were updated: b4; b5; g3; g6; h1; h2; h6 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.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00599-4, 0001825034-2021-00616-4, 0001825034-2021-00617-4, 0001825034-2021-00619-4, 0001825034-2021-00620-4, 0001825034-2021-00621-4.The additional information does not change root cause of previous investigation.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmern biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
UNKOWN LOCKING SCREW
Type of Device
IMPLANT, EXTREMETIES
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11411069
MDR Text Key234637356
Report Number0001825034-2021-00618
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN LOCKING SCREW
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberNI
Patient Sequence Number1
Treatment
MEDICAL PRODUCTS: SEE H10.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age32 YR
Patient Weight82
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