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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TWIN-PEG FEMORAL MD; KNEE PROSTHESIS

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BIOMET UK LTD. OXFORD UNI TWIN-PEG FEMORAL MD; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Swelling (2091)
Event Date 11/26/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Udi# (b)(4).Report source: (b)(6).Concomitant medical products: medical product: oxf uni tib tray sz e lm pma catalog #: 154726 lot #: 3804822, medical product: oxf anat brg lt md size 3 pma catalog #: 159547 lot #: 3777301.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00921, 3002806535-2019-00922.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient contained to be experiencing pain, swelling and instability in left knee.
 
Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in (b)(6).Concomitant medical products: medical product: oxf uni tib tray sz e lm pma, catalog #: 154726, lot #: 3804822, medical product: oxf anat brg lt md size 3 pma, catalog #: 159547, lot #: 3777301.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00921-1, 3002806535-2019-00922-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 1 similar complaint reported with the item 166942,6 similar complaints reported with the item 154726 and 11 similar complaints reported with the item 159547.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.The reported event states ¿pain¿.In the above risk file, pain is considered harm with a severity level of 3 for a number of hazards defined as moderate, which is described in the severity table as: s-3 prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.Swelling and instability are also considered as harms for multiple lines in the risk file (skn002.Rmr.04 rev 04) with a severity score not exceeding 3.The outcome of this complaint is therefore considered to be within the severity of the rmr.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 underwent an initial left knee replacement procedure.On (b)(6), 2019, it was reported that the patient contained to be experiencing pain, swelling and instability in left knee.
 
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Brand Name
OXFORD UNI TWIN-PEG FEMORAL MD
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key9457991
MDR Text Key170475605
Report Number3002806535-2019-00920
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number166942
Device Lot NumberJ3693126
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age59 YR
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