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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEGMENT WITH MALE/FEMALE TAPER 100 MM LENGTH PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. SEGMENT WITH MALE/FEMALE TAPER 100 MM LENGTH PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 12/16/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated report: 0001822565-2020-04190. , 0001822565-2020-04192, 0001822565-2020-04193, 0001822565-2020-04194 concomitant medical products: distal femoral xt component size b left, item# 00585004201, lot# 64833183. Segment with male/female taper 40 mm length, item# 00585004604, lot# 64243509. Segment with male/male taper 80 mm length, item# 00585004808, lot# 63929410. Articular surface with segmental hinge post size b 12 mm height, item# 00585002012, lot# 64423658. Report source - (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.
 
Event Description
It was reported that a patient was revised approximately six weeks post implantation due to infection. There is no additional information at this time.
 
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Brand NameSEGMENT WITH MALE/FEMALE TAPER 100 MM LENGTH
Type of DevicePROSTHESIS, KNEE
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 Key11059480
MDR Text Key223367202
Report Number0001822565-2020-04191
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K070978
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00585004610
Device Lot Number64364382
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/22/2020 Patient Sequence Number: 1
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