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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 5 PMA; KNEE PROSTHESIS

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BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 5 PMA; KNEE PROSTHESIS Back to Search Results
Catalog Number 159584
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 10/11/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).D10 - associated products: oxford ph3 cementless fem sz l; item# 154927; lot# 7399003.Oxf uni cmntls tib sz e rm; item# 166579; lot# 7302023.G2 - foreign: australia.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that six months post initial right knee arthroplasty, the patient had to undergo a revision surgery for a dislocated bearing.Dislocation occurred while patient was riding a bike.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 information.Visual examination of the provided pictures identified an explanted oxford bearing.Nothing further could be gained from the photos.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Radiographs were provided but were not sent for radiologist review as they are not dated.They do however confirm a dislocated bearing.With the available information, a definitive root cause could not 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
No further event information available at the time of this report.
 
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Brand Name
OXF ANAT BRG RT LG SIZE 5 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 Key18083842
MDR Text Key327520694
Report Number3002806535-2023-00375
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279786305
UDI-Public(01)05019279786305(17)270616(10)7269022
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/19/2023
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 Catalogue Number159584
Device Lot Number7269022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/11/2023
Initial Date FDA Received11/07/2023
Supplement Dates Manufacturer Received12/14/2023
Supplement Dates FDA Received12/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexMale
Patient Weight108 KG
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