MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS COCR SIZE B LM STD; PROSTHESIS, KNEE

Catalog Number 154720

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: oxford pks femoral cocr medium, catalog #: 154601.Lot #: 1091989; and oxf anat brg lt md size 5 pma, catalog #: 159549, lot #: 925893.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.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 report: 3002806535-2017-00281.

Event Description

It was reported the patient underwent a left partial knee arthroplasty.Subsequently, the patient underwent a revision procedure approximately nine years post-implantation due to loosening/malalignment.All components were removed and replaced with total knee implants.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from 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 PKS COCR SIZE B LM STD
• 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: 6549627
• MDR Text Key: 74581818
• Report Number: 3002806535-2017-00282
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: 154720
• Device Lot Number: 898411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 05/05/2017
• Supplement Dates Manufacturer Received: 12/26/2017
• Supplement Dates FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2005
• 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): Hospitalization; Required Intervention
• Patient Age: 89 YR