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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGXP XP INLK PRI TIB TRAY 67MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. VGXP XP INLK PRI TIB TRAY 67MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Date 05/02/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03935, 0001825034-2020-03936, 0001825034-2020-03963, and 0001825034-2020-03964. Medical devices: vgxp xp e1 tib brg rm 11x63 catalog#: 195844 lot#: 641580, vgxp intlk femoral rt 62. 5 catalog#: 195909 lot#: 758590, vgxp xp e1 tib brg rl 9x63 catalog#: 195772 lot#: 852680, series a pat std 31 3 peg catalog#: 184764 lot#: 236110. 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 patient is experiencing pain approximately five years after implantation. No revision procedure has been reported. Attempts have been made and no further information has been provided.

 
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Brand NameVGXP XP INLK PRI TIB TRAY 67MM
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 Key10763911
MDR Text Key213928327
Report Number0001825034-2020-03937
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/14/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number195753
Device LOT Number206970
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 Received04/23/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/03/2014
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: 10/30/2020 Patient Sequence Number: 1
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