MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM LG PMA; OXFORD CEMENTED FEMORALS

Catalog Number 161470

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products- oxf anat brg lt lg size 3 pma ,item 159554, lot 086850, therapy date - (b)(6) 2018, oxf uni tib tray sz d lm pma , item 154724, lot 090560, therapy date - (b)(6) 2018.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01207 and 3002806535-2018-01208.

Event Description

Revision due to unknown reason.

Event Description

Knee revision due to unknown reasons.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) wasreviewed and no discrepancies were found.Root cause was unable to be determined.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: OXF TWIN-PEG CMNTD FEM LG PMA
• Type of Device: OXFORD CEMENTED FEMORALS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8098914
• MDR Text Key: 128182897
• Report Number: 3002806535-2018-01209
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 161470
• Device Lot Number: 329920
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• 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