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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ D RM PMA; OXFORD PARTIAL KNEE SYSTEM

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BIOMET UK LTD. OXF UNI TIB TRAY SZ D RM PMA; OXFORD PARTIAL KNEE SYSTEM Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 08/24/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial report: customer has indicated that the product has been discarded, therefore will not be returned to zimmer biomet for investigation.Medical product: oxf twin-peg cmntd fem lg pma, catalog #:161470, lot #: 915290 medical product: oxf anat brg rt lg size 4 pma, catalog #:159583, lot #: 169240 multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-,00372, 3002806535-2021-00373.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2016.Subsequently, a revision procedure due to pain was performed on (b)(6) 2021.Attempts have been made but no further information has been provided at this time.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.Complaint summary: 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 any supporting documentation which could provide additional information.The source of pain cannot be determined through the radiographs, as only ap radiographs provided, no ml view so a full assessment of size, position and alignment cannot be done.A review of the manufacturing history records confirms no abnormalities or deviations reported, ncr9101 and ncr006868 were issued for item 161470 and ncr0024 was issued for item 154725.A review of the complaint database over the last 3 years has found 4 complaints reported with the item 159583, 5 complaints reported with the item 161470 and 6 complaints reported with the item 154725 (including the initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00372-1, 3002806535-2021-00373-1.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that a patient underwent an initial right knee arthroplasty on (b)(6), 2016.Subsequently, a revision procedure due to pain was performed on (b)(6), 2021.Attempts have been made but no further information has been provided at this time.
 
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Brand Name
OXF UNI TIB TRAY SZ D RM PMA
Type of Device
OXFORD PARTIAL KNEE SYSTEM
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key12406919
MDR Text Key272963725
Report Number3002806535-2021-00374
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279388912
UDI-Public(01)05019279388912(17)261118(10)734830
Combination Product (y/n)N
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 10/13/2021
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? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number154725
Device Lot Number734830
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/24/2021
Initial Date FDA Received09/01/2021
Supplement Dates Manufacturer Received10/13/2021
Supplement Dates FDA Received10/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age65 YR
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