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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 4 PMA; KNEE PROSTHESIS

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BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 4 PMA; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported by the hospital that when removing the peel-off seal it was recognized that a part of about 1 cm wasn't welded with the plastic packaging.Subsequently, the sterility could not be ensured, therefore the implant wasn't used.
 
Event Description
It was reported by the hospital that when removing the peel-off seal it was recognized that a part of about 1 cm wasn't welded with the plastic packaging.Subsequently, the sterility could not be ensured, therefore the implant wasn't used.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The reported event (damaged pouch) has been confirmed through visual inspection of the returned packaging, which confirms the inner sterile barrier (pouch) is damaged.The likely condition of the device when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be transit damage.Device history record (dhr) was reviewed and no discrepancies were found.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.
 
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Brand Name
OXF ANAT BRG LT SM SIZE 4 PMA
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key8721951
MDR Text Key148966630
Report Number3002806535-2019-00530
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279785872
UDI-Public05019279785872
Combination Product (y/n)N
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/15/2023
Device Model NumberN/A
Device Catalogue Number159541
Device Lot Number6450620
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/05/2019
Initial Date FDA Received06/21/2019
Supplement Dates Manufacturer Received09/17/2019
Supplement Dates FDA Received09/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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