MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANATOMIC BEARING RIGHT MD SIZE 8 PMA; PROSTHESIS, KNEE

Catalog Number 159580

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 03/31/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - oxford uni femoral md, catalog #: 154601, lot #: 447847 and oxf uni tib tray sz d rm pma, catalog #: 154725, lot #: 278419.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 3002806535-2017-00283 and 3002806535-2017-00284.

Event Description

It was reported the patient underwent a right total hip arthroplasty.Subsequently, the patient underwent a revision seven years post-implantation due to patient allegations of pain and inability to bear weight.Attempts have been made and additional information on the reported event is unavailable at this time.This report is based on allegations set forth in patient's complaint, and the allegations contained therein are unverified.Operative reports revealed that radiographs obtained in the emergency department indicate displaced polyethylene insert in the right unicompartmental knee.There is marked right knee effusion with diffuse tenderness.Range of motion is limited.There is mild increased warmth.This is most likely due to hemarthrosis.

Manufacturer Narrative

Udi# - (b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 ANATOMIC BEARING RIGHT MD SIZE 8 PMA
• 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: 6549794
• MDR Text Key: 74581094
• Report Number: 3002806535-2017-00285
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2018

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: 06/30/2011
• Device Catalogue Number: 159580
• Device Lot Number: 195337
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 05/05/2017
• Supplement Dates Manufacturer Received: Not provided; 12/05/2017
• Supplement Dates FDA Received: 06/07/2017; 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2006
• 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: 63 YR