MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; KNEE PROSTHESIS

Catalog Number 161468

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - oxf uni tib tray sz b lm pma , item 154720, lot 128990, therapy date - (b)(6) 2018, oxf anat brg lt sm size 5 pma, item 1595428, lot 800570, 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: 3002806535-2018-01297 and 3002806535-2018-01299.

Event Description

Revision due to unknown reason.

Event Description

Left knee revision due to unknown reasons.

Manufacturer Narrative

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

Left knee revision due to unknown reasons.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Unique identifier (udi) number: (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: OXF TWIN-PEG CMNTD FEM SM PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8187079
• MDR Text Key: 131130053
• Report Number: 3002806535-2018-01298
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 161468
• Device Lot Number: 567310
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2019
• 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