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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 3 PMA; KNEE ARTHROPLASTY
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BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 3 PMA; KNEE ARTHROPLASTY Back to Search Results
Model Number N/A
Device Problem Mechanical Problem (1384)
Patient Problem Loss of Range of Motion (2032)
Event Date 12/30/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Concomitant medical products: medical product: oxf uni tib tray sza lm, catalog #: 154718, lot #: 107070.Medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 400140.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00024, 3002806535-2021-00025.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.
 
Event Description
It was reported that an initial left unilateral tka was performed on (b)(4) 2020.Subsequently, the patient had a manipulation under anaesthesia (mua) on (b)(4) 2020 due to stiffness and limited mobility.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00024-1, 3002806535-2021-00025-1.Additional information received: -operative notes received.-patient information received: patient name: (b)(6).Patient age: 43 years.The investigation is in process.Once the investigation has been completed, a supplemental mdr will be submitted.
 
Event Description
It was reported that an initial left unilateral tka was performed on (b)(6) 2020.Subsequently, the patient had a manipulation under anaesthesia (mua) on (b)(6) 2020 due to stiffness and limited mobility.
 
Event Description
It was reported that an initial left unilateral tka was performed on (b)(6) 2020.Subsequently, the patient had a manipulation under anaesthesia (mua) on (b)(6) 2020 due to stiffness and limited mobility.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00024-2, 3002806535-2021-00025-2.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, 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 (b)(4) complaints reported with the item 154718,(b)(4) complaints reported with the item 161468 and (b)(4) complaints reported with the item 159540 including initiating complaint.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
 
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Brand Name
OXF ANAT BRG LT SM SIZE 3 PMA
Type of Device
KNEE ARTHROPLASTY
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key11228852
MDR Text Key228692739
Report Number3002806535-2021-00026
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279785865
UDI-Public05019279785865
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,health
Type of Report Initial,Followup,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number159540
Device Lot Number562700
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age43 YR
Patient Weight93
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