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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD ARTHRO 7 DEG LCK COLLAR PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. MOD ARTHRO 7 DEG LCK COLLAR PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Separation Failure (2547)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00231 and 0001825034-2020-00232. Concomitant medical products: mod arthro nl 1 cm diasl cnctr, catalog#: cp260605, lot#: 236860. Mod arthro nl 1 cm diasl cnctr, catalog#: cp260605, lot#: 161950. Oss porous im stem 21. 5 x 150, catalog#: 150400, lot#: 360910. Oss porous im stem 18. 5 x 225, catalog#: 150405, lot#: 898500. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that during a revision of a left knee oss system due to a broken junction/connector component, the surgeon stated that the morris taper could not be broken from the femoral stem despite multiple attempts and different instruments. The surgery had to be modified to cut the segments apart, extending surgical time by an hour.
 
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Brand NameMOD ARTHRO 7 DEG LCK COLLAR
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 Key9580992
MDR Text Key195163798
Report Number0001825034-2020-00232
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042409
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberCP260602
Device Lot Number968130
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 Received05/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2017
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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