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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DIST MED HUM LK PLT SHRT 3H RT; PLATE, FIXATION
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ZIMMER BIOMET, INC. DIST MED HUM LK PLT SHRT 3H RT; PLATE, FIXATION Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Material Discolored (1170)
Patient Problems Cellulitis (1768); Unspecified Infection (1930); Irritation (1941); Nerve Damage (1979); Pain (1994); Swelling (2091); Reaction (2414)
Event Date 04/17/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: 47235800505, periart locking plate elbow st, 62685139.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001822565-2018-02571.Discarded.
 
Event Description
It was reported that the patient was revised due to infection, pain, soft tissue irritation, allergies, and swelling.During removal of the plate, rust or discoloring were identified on the plate and screws.Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was revised due to ulnar nerve symptoms.Two months prior to removal, patient presented with symptoms: warm, swollen, erythematous and crp <8.During removal of the plate, rust or discoloring were identified on the plate and screws.Metallosis was also noted.Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.
 
Event Description
It was reported that the patient was revised due to ulnar nerve symptoms and infection.Two months prior to removal, patient presented with symptoms: infection, warm, swollen, erythematous and crp less than 8, which were treated with 2 separate courses of oral antibiotics.During removal of the plate, rust or discoloring were identified on the plate and screws.Metallosis was also noted.Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of pictures of product provided and pathology report.As per the pathology report, adverse reaction to metallic debris/metallosis has been noted.But, there is no date of when the specimens were taken or pathology report.Dhr was reviewed and no discrepancies relevant to the reported event were found.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 was revised due to ulnar nerve symptoms and infection.Two months prior to removal, patient presented with symptoms: infection, warm, swollen, erythematous and crp less than 8, which were treated with 2 separate courses of oral antibiotics.During removal of the plate, rust or discoloring were identified on the plate and screws.Metallosis was also noted.Attempts have been made and additional information on the reported event is unavailable.
 
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Brand Name
DIST MED HUM LK PLT SHRT 3H RT
Type of Device
PLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7503918
MDR Text Key107903201
Report Number0001822565-2018-02572
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
PK082078
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup,Followup,Followup
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date01/31/2019
Device Model NumberN/A
Device Catalogue Number47235810703
Device Lot Number61153867
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age65 YR
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