MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ C RM PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: medical product: oxf anat brg rt lg size 3 pma lrg sz 3 catalog #: 159582 lot #: 6029891, medical product: oxford uni twin-peg femoral lg cocr lrg catalog #: 166943 lot :j3774095, associated product: cmt cmw t.2 sans antibiotique catalog #:3322020 lot #: 8751042.Remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00809, 3002806535-2019-00808.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported by the hospital that eczema developed on a patient following implantation of an oxford right knee prosthesis.

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.

Event Description

It was reported by the hospital that eczema developed on a patient following implantation of an oxford right knee prosthesis.

• Brand Name: OXF UNI TIB TRAY SZ C RM PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9165551
• MDR Text Key: 161577394
• Report Number: 3002806535-2019-00810
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00501927938889
• UDI-Public: 0501927938889
• 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
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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: 154723
• Device Lot Number: 3876563
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization