MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD TWIN-PEG CEMENTED FEMUR MD PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Muscular Rigidity (1968)

Event Date 02/07/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdrs were submitted for this event.Please see reports: 3002806535 - 2017 - 01017, 3002806535 - 2017 - 01018.Unique device identifier: ((b)(4).Concomitant product(s): a 161469 oxf twin-peg cmntd fem md pma lot 2465500.A 154724 oxf uni tib tray sz d lm pma lot 2462031.A 159547 oxf anat brg lt md size 3 pma lot 2485165.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported in the study the patient experienced an increase in left knee stiffness.It was determined no treatment was necessary and the outcome was considered resolved.No further information has been made available.

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 TWIN-PEG CEMENTED FEMUR MD 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: 7037419
• MDR Text Key: 92195940
• Report Number: 3002806535-2017-01017
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 161469
• Device Lot Number: 2465500
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2011
• 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: 79 YR
• Patient Weight: 79