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

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Damaged sterile packaging.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Device history record (dhr) was reviewed and no discrepancies were found.Visual inspection confirmed the reported event.A clean and sharp cut is visible in the middle of the pouch.The corner of the pouch is torn.The implant was in the field for approximately 7 years and 11 months.The mhr review confirmed that the item was manufactured to specifications, therefore it is most likely that the defect occurred in transit or during prolong storage.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

Damaged sterile packaging.

• Brand Name: OXF UNI TIB TRAY SZ D LM PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8208076
• MDR Text Key: 131780057
• Report Number: 3002806535-2019-00006
• 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
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2021
• Device Model Number: N/A
• Device Catalogue Number: 154724
• Device Lot Number: 2474498
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1