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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
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.

 
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Brand NamePATELLA REAMER BLADE
Type of DeviceREAMER
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 Key8743537
Report Number0001822565-2019-02703
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/18/2019
1 Device Was Involved in the Event
0 PatientS WERE 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
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/14/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/01/2019
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

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