MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PARTIAL KNEE SYSTEM TWIN PEGGED CEMENTLESS FEMUR V6 MEDIUM; PROSTHESIS, KNEE

Catalog Number 161474

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091)

Event Date 05/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: oxf anat brg lt md size 3 pma catalog #: 159547 lot #: 644610 and oxford cementless tibia d lm catalog #: us166576 lot #: r262351.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-00472 and 3002806535-2017-00473.Remains implanted.

Event Description

It was reported the patient underwent a left partial knee arthroplasty.Subsequently, the patient experienced swelling, pain, and limping approximately five months post-implantation.The patient underwent an aspiration in the clinic, was injected with bethamethasone and given antibiotics.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.

Manufacturer Narrative

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: OXFORD PARTIAL KNEE SYSTEM TWIN PEGGED CEMENTLESS FEMUR V6 MEDIUM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6619787
• MDR Text Key: 76938864
• Report Number: 3002806535-2017-00471
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 161474
• Device Lot Number: R2494936A
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 115