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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 159541
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Foreign: (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported the inlay (bearing) fractured after cementless knee implantation in 2008, without adequate trauma.No remedial action has been reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10: associated products: item number: 154925, item name: oxford ph3 cementless fem sz s, item lot: unknown item number: 154915, item name:oxf ph3 cementless tib sz b lm, item lot: unknown no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product lot number being provided.Review of complaint history identified additional similar complaints for the reported item.As the lot number is unknown, an additional review could not be performed.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Device is used for treatment.Radiographs were provided and reviewed by a health care radiologist.Impressions are narrowing of the medial compartment noted on images acquired at and after 08/09/2021 which is suggestive of nonspecific disruption or wear of the polyethylene lining in this region.This results in narrowing of the medial compartment joint space.Medical records were not provided.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that the patient underwent a bearing revision due to fracture without adequate trauma, approximately 15 years post-op.
 
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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
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK   CF31 3XA
Manufacturer Contact
christina arnt
.
warsaw, IN 46582
5745273773
MDR Report Key16442278
MDR Text Key310227920
Report Number3002806535-2023-00048
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/08/2023
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 Model Number159541
Device Catalogue Number159541
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/23/2023
Initial Date FDA Received02/27/2023
Supplement Dates Manufacturer Received05/04/2023
Supplement Dates FDA Received05/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10
Patient Outcome(s) Required Intervention; Other; Hospitalization;
Patient Age80 YR
Patient SexFemale
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