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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 01/05/2015

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Multiple mdr's were reported for this event.Please also see associated events: 3002806535-2018-00489, 3002806535-2018-00491.Concomitant medical products: 161469, oxf twin-peg cmntd fem md pma lot 534340.Cat 154725 ¿ lot 507470 ¿ oxford pks cocr size d rm std.Cat 159575 ¿ lot 215120 ¿ oxf anat brg rt md pma.This report is being submitted late as it has been identified in remediation reported event was unable to be confirmed due to limited information received from the customer.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.Device remains implanted.

Event Description

It was reported in clinical study (b)(6) that a patient had post-operative pain and other experiences were reported at the follow up visits: 6 month eq5d - problems walking about, problems performing usual activities, extreme pain and oxford - severe pain, very painful to stand up, extremely difficult to kneel, troubled by pain in bed every night, greatly interfered with usual work, moderately difficult to shop, moderately difficult to walk down stairs; 1 year eq5d - moderate pain; knees - moderate pain and oxford - moderate pain, and moderately difficult to kneel.At this time there is no indication of surgical delays or medical intervention.Attempts have been made and no further information has been made available at this time.

• Brand Name: OXFORD PKS COCR SIZE D RM 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: 7344794
• MDR Text Key: 102597263
• Report Number: 3002806535-2018-00490
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 154725
• Device Lot Number: 507470
• Other Device ID Number: (01) 05019279388912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 74