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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product - item #:159548, oxf anat brg lt md size 4 pma, lot #: 506010.Medical product - item #: 161469, oxf twin-peg cmntd fem md pma, lot #: 137290.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-01176, 3002806535-2017-01177.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that a patient underwent revision surgery due to pain.

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.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 D LM STD
• Type of Device: KNEE PROSTHESIS
• 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: 7086271
• MDR Text Key: 93825681
• Report Number: 3002806535-2017-01174
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154724
• Device Lot Number: 583010
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10; SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR