MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Unstable (1667); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Reaction (2414)

Event Date 11/07/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products ¿ oxford anatomic bearing size 8 catalog 159580 lot 1195337; oxford tibial tray size d catalog 154725 lot 1278419.Customer has not indicated whether product will 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: 3002806535-2017-00543, 3002806535-2017-00542.

Event Description

It was reported a patient underwent a revision procedure to convert from a right partial knee prosthesis to a total knee approximately seven years post implantation due to pain, wear, instability, and arthroplasty collapse with migration.The patient reportedly began experiencing pain and instability approximately three and a half years post-operatively, however no issues were found until the patient began experiencing worsening pain approximately seven years post-operatively.The femoral and tibial components were said to have been in contact with one another and were noted to have evidence of gross abrasive wear.The tibial bearing was also noted to evidence asymmetrical wear.

Manufacturer Narrative

This follow-up report is being filed to relay this report is a duplicate of 3002806535-2017-00283.

• Brand Name: OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL
• 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: 6686528
• MDR Text Key: 79064939
• Report Number: 3002806535-2017-00541
• 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,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 154601
• Device Lot Number: 1447847
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention