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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL CUT BLOCK HANDLE KNEE INSTRUMENT

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ZIMMER BIOMET, INC. FEMORAL CUT BLOCK HANDLE KNEE INSTRUMENT Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 01/10/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: vanguard premier block, catalog #: 32-487104, lot #: zb060802. 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. 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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. Visual inspection confirms the cut block handle has fractured and the fractured piece is in the cut block guide. Visual inspection found signs of wear and damage. Scratches, nicks and gouge marks were identified on the returned devices. Dhr was reviewed and no discrepancies were found. Root cause is wear and tear from use. 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)(4). Concomitant medical products: femoral cut block handle catalog # 32-487104 lot # unknown. (b)(6). Product has not been returned to zimmer biomet. 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 - 00362.
 
Event Description
It was reported that during a knee arthroplasty procedure, the instrument fractured during use. All pieces were recovered from the surgical site, and the site was extensively irrigated.
 
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Brand NameFEMORAL CUT BLOCK HANDLE
Type of DeviceKNEE INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7249250
MDR Text Key255855609
Report Number0001825034-2018-00366
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
PMA/PMN Number
PEXEMPT
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 06/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number32-487110
Device Lot NumberZB070209
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/07/2018 Patient Sequence Number: 1
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