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

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the packaging was not vacuum sealed.Another the same size product was used to complete the procedure.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10.Visual inspection confirmed the reported event.The likely root cause of the reported event is the operator selecting the incorrect program during sealing operation.Device history record (dhr) was reviewed and no discrepancies were found.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 that the packaging was not vacuum sealed.Another the same size product was used to complete the procedure.

• Brand Name: OXF TWIN-PEG CMNTD FEM XS PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8455831
• MDR Text Key: 139993965
• Report Number: 3002806535-2019-00304
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2021
• Device Model Number: N/A
• Device Catalogue Number: 161467
• Device Lot Number: 2447059
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 09/28/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 60 YR