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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 3 PMA; KNEE PROSTHESIS

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BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 3 PMA; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Type  Injury  
Event Description
The patient underwent an initial left knee hemiarthroplasty.Subsequently, the patient experienced loosening, swelling, and difficulty ambulating.No revision procedure has occurred at this time.Due diligence is in progress for this complaint; to date, no additional information or product has been received.
 
Manufacturer Narrative
Cmp-(b)(4).Concomitant medical products: item#: 161470; lot#: unknown; item#: 154724; lot#: unknown.Therapy date: unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see the associated reports: 3002806535 -2022 -00420; 3002806535 -2022 -00421.
 
Manufacturer Narrative
Cmp-(b)(4).This follow-up report is being submitted to relay additional information.Part and lot identification are necessary for review of device history records, neither were provided.Medical records and radiographs were provided and reviewed by a healthcare professional.Review of the available records identified the following: interval postsurgical changes compatible with a hemiarthroplasty of the medial compartment of the left knee, mild osteoarthritic change of the lateral and patellofemoral compartments, enthesophyte noted along the quadriceps tendon insertion site upon the patella, tiny suprapatellar joint effusion is suspected.Contributing factor of the event is obesity a definitive root cause cannot be determined.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
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4).D10: item#: 154724; lot#: 955030.Item#: 161470; lot#: 674580.This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d10, g3, g6, h4, h6, h10.This complaint was re-opened due to further medical notes becoming available which also includes lot numbers being established.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Medical notes being received and these were reviewed by a health care professional who reported that initial xray: chronic pain, x-ray: possible hardware loosening, discussed possible revision, pain meds provided.Second x-ray: no fracture, effusion, swelling, or calcifications; unchanged degree of lucency in the medial femoral condyle and medial tibial plateau.Third x-ray: demineralization of the bones, components in similar alignment as compared to previous xrays, degenerative changes to patellofemoral compartment, no fracture, small joint effusion, mild soft tissue swelling, lucency at the bone cement interface.The root cause of the reported issue is remains to be attributed to patient condition being disease progression.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.This complaint was re-opened due to medical notes being received and these were reviewed by a health care professional who reported that the revision occurred due to severe arthritic changes in the knee.The partial knee components were found to be well-fixed during the revision.A competitor total knee was placed without complications.The root cause of the reported issue is attributed to patient condition being disease progression.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 revision surgery due to loosening, swelling, difficulty ambulating, and severe arthritic changes in the knee.
 
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Brand Name
OXF ANAT BRG LT LG SIZE 3 PMA
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK   CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key15560367
MDR Text Key301336951
Report Number3002806535-2022-00422
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 12/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/25/2022
Device Model NumberN/A
Device Catalogue Number159554
Device Lot Number313150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/09/2022
Initial Date FDA Received10/07/2022
Supplement Dates Manufacturer Received11/02/2022
10/06/2023
11/09/2023
Supplement Dates FDA Received11/29/2022
11/02/2023
12/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Other;
Patient SexMale
Patient Weight136 KG
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