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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 65MM KNEE PROSTHESIS

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ZIMMER BIOMET, INC. VGXP XP INLK PRI TIB TRAY 65MM KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Bone Fracture(s) (1870); Pain (1994)
Event Date 12/22/2015
Event Type  Injury  
Manufacturer Narrative
The follow-up report is being submitted to relay additional information. 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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Concomitant medical products: 195909, vgxp intlk femoral rt 62. 5, 029390; 195772, vgxp xp e1 tib brg rl 9x63, 526870; 195842, vgxp xp e1 tib brg rm 9x63, 335190. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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 that the patient experienced a fracture of the anterior bony island on an unknown date that required re-fixation using ethibond.
 
Manufacturer Narrative
The follow-up report is being submitted to relay additional information. 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.
 
Manufacturer Narrative
(b)(6). Additional concomitant medical products: unknown vangaurd tibial component catalog # unknown lot # unknown; unknown vangaurd articular surface catalog # unknown lot # unknown. Customer has indicated that the product will not be returned because it remains implanted. The investigation is in process. Once the investigation  has been completed, a follow-up mdr will be submitted.   multiple mdr reports were filled for this event: 0001825034-2018-00276, 0001825034-2018-00277. Remains implanted.
 
Event Description
It is reported that the patient underwent a knee arthroplasty. Subsequently, the patient required injections to treat post-operative pain.
 
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Brand NameVGXP XP INLK PRI TIB TRAY 65MM
Type of DeviceKNEE PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7189697
MDR Text Key113043800
Report Number0001825034-2018-00275
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
PK132873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup,Followup,Followup
Report Date 04/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2018
Device Model NumberN/A
Device Catalogue Number195752
Device Lot Number450410
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/15/2018 Patient Sequence Number: 1
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