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

Model Number N/A

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

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

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.

Event Description

During a knee replacement surgery, it was discovered that the plastic wrapping surrounding the implant was torn.Since the outer container was intact, surgeon implanted tibial component.

Event Description

During a knee replacement surgery, it was discovered that the plastic wrapping surrounding the implant was torn.Since the outer container was intact, surgeon implanted tibial component.

Manufacturer Narrative

(b)(4).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.

• Brand Name: OXF UNI TIB TRAY SZ C RM PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8494725
• MDR Text Key: 141450813
• Report Number: 3002806535-2019-00360
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154723
• Device Lot Number: 3624664
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 78