MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF TWIN-PEG CMNTD FEM LG PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 08/05/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see associated reports: 0001825034 - 2018 - 01434, 0001825034 - 2018 - 01435.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.Review of the complaint history determined that no further action is required as no were trends identified.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 453 one patient underwent right knee surgery on (b)(6) 2014.Subsequently, post-operative pain and other experiences were reported at the follow up visits: post op visit eq5d - some problems walking, unable to perform usual activities, moderate pain and oxford - moderate pain, troubled by pain in bed most nights, pain has moderately interfered with usual work, and moderately difficult to go down stairs.1 year - eq5d - some problems walking, moderate pain; oxford - often limping, moderately difficult to kneel, and troubled in bed by pain most nights.At this time there is no indication of surgical delays or medical intervention.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 3002806535 - 2018 - 00531.

• Brand Name: OXF TWIN-PEG CMNTD FEM LG PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7335941
• MDR Text Key: 102300997
• Report Number: 0001825034-2018-01433
• 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,Followup
• Report Date: 03/20/2018

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: Physician
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 161470
• Device Lot Number: 317380
• Other Device ID Number: (01) 05019279438259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2014
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2014
• 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: 49 YR
• Patient Weight: 83