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 Necrosis (1971)

Event Date 01/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: oxf twin peg cmntls fmrl lg, catalog #: 161475, lot #: r3050589a; oxf anat brg rt lg size 3 pma, catalog #: 159582, lot #: 323040.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00645, 3002806535-2019-00644.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported by the the clinical study that a patient underwent a revision due to avascular necrosis.

Event Description

It was reported by the the clinical study that a patient underwent a revision due to avascular necrosis.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.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: 8854268
• MDR Text Key: 153071750
• Report Number: 3002806535-2019-00646
• 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: health professional,study
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: US166579
• Device Lot Number: R3050491A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 100