MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD CEMENTLESS TIBIA E RM; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Aspiration/Inhalation (1725)

Event Date 11/14/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535 -2019 -00525, 3002806535-2019-00524.Concomitant medical products: medical product: oxf twin-peg cmntd fmrl md, catalog #: 161474, lot #: 2409868.Medical product: oxf anat brg rt md size 3 pma, catalog #: 159575, lot #: 948670.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the hospital that a patient had right knee arthroplasty.Subsequently, the patient suffered a large effusion which was treated with aspiration.It was also reported that the same patient suffered a further three occurrences of effusion.

Event Description

It was reported by the hospital that a patient underwent right knee arthroplasty.Subsequently, the patient suffered a large effusion which was treated with aspiration.It was also reported that the same patient suffered a further three occurrences of effusion.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.On the radiographs taken at the 2-year follow-up visit and following visits, medial femoral osteophytes can be seen on the antero-posterior radiographs and anterior femoral osteophytes can be seen on the medio-lateral radiographs.Kss scores and oxford knee scores recorded in the crf report show improvement from the 6-month to the 4-year assessment.At the 4 year followup, the patient had a kss assessment score of 98 and a kss functional score of 100, which can be considered excellent and would indicate that the recurrent joint effusions prior to this point were not related to the function of the device.The adverse event reports for each of these events also specifically state that they were not related to the device.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: OXFORD CEMENTLESS TIBIA E RM
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8748151
• MDR Text Key: 149636876
• Report Number: 3002806535-2019-00526
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: US166579
• Device Lot Number: 3050489
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 80