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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMER BLADE
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ZIMMER BIOMET, INC. PATELLA REAMER BLADE Back to Search Results
Catalog Number 00597909541
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Multiple mdr's were filed in association with this reporting: 0001822565 - 2019 - 02701, 0001822565 - 2019 - 02702, 0001822565 - 2019 - 02703, 0001822565 - 2019 - 02704, 0001822565 - 2019 - 02705, 0001822565 - 2019 - 02706.Concomitant medical products: 00590103533 hex screw lot 61627212: (01)00889024201699; 00597909541 reamer lot 64192658: (01)00889024217522; 00597909541 reamer lot 64264651: (01)00889024217522; 00598004702 stemmed tibia lot 64020358: (01)00889024217614; 00598009000 stem extension lot 64062432: (01)00889024217669; 42512400412 art surface lot 63395715: (01)00889024237025.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified.No patient or surgical involvement.No further information available at this time.
 
Manufacturer Narrative
It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.
 
Event Description
It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.
 
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Brand Name
PATELLA REAMER BLADE
Type of Device
REAMER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8743537
MDR Text Key149504382
Report Number0001822565-2019-02703
Device Sequence Number1
Product Code HTO
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00597909541
Device Lot Number64264651
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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