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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL LATERAL FEMORAL PLATE RIGHT 14 HOLES 286 MM LENGTH PROSTHESIS, TRAUMA

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ZIMMER BIOMET, INC. DISTAL LATERAL FEMORAL PLATE RIGHT 14 HOLES 286 MM LENGTH PROSTHESIS, TRAUMA Back to Search Results
Catalog Number 00235710114
Device Problem Fracture (1260)
Patient Problems Adhesion(s) (1695); Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Non-union Bone Fracture (2369); Osteopenia/ Osteoporosis (2651)
Event Date 09/14/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Foreign - event occurred in (b)(6). Other - reported by (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the 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 by (b)(6) that a patient was revised approximately two (2) years post-implantation due to implant fracture. Patient was experiencing pain but no other symptoms, and it is unknown what caused the implant to fracture. Attempts have been made and no further information has been provided.
 
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Brand NameDISTAL LATERAL FEMORAL PLATE RIGHT 14 HOLES 286 MM LENGTH
Type of DevicePROSTHESIS, TRAUMA
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 Key12676896
MDR Text Key278116524
Report Number0001822565-2021-03085
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K042598
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00235710114
Device Lot Number64302552
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 10/21/2021 Patient Sequence Number: 1
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