MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

During an oxford knee replacement surgery, it was found that the product was not consistent with the label on the packaging.A replacement device was obtained which caused a 15 minute delay to surgery.

Event Description

During an oxford knee replacement surgery, it was found that the product was not consistent with the label on the packaging.A replacement device was obtained which caused a 15 minute delay to surgery.

Manufacturer Narrative

(b)(4).A visual inspection confirmed the reported event and revealed that a left handed bearing had been supplied within the package labeled for a right handed bearing.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported event is attributed to a manufacturing issue.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8490631
• MDR Text Key: 141167073
• Report Number: 3002806535-2019-00356
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2024
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 6461000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: ZFA 2019-00113
• Patient Sequence Number: 1