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

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Information (3190)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Inner sterile packaging damaged.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The reported event (damaged pouch) has been confirmed through visual inspection of the returned packaging, which confirms the inner sterile barrier (pouch) is damaged.The likely condition of the device when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be transit damage.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

Inner sterile packaging open.

• Brand Name: OXF UNI TIB TRAY SZ B 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: 8366291
• MDR Text Key: 137063052
• Report Number: 3002806535-2019-00147
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2021
• Device Model Number: N/A
• Device Catalogue Number: 154720
• Device Lot Number: 2448172
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1