MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXFORD UNI FEMORAL LG; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were reported for this event.Please also see associated events: 0001825034 - 2018 - 01628, 0001825034 - 2018 - 01629.Concomitant medical products: 154722 oxf uni tib tray sz c lm pma lot 3376951, 159555 oxf anat brg lt lg size 4 pma lot 3452312.Report source: foreign.The event occurred in (b)(6).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 furth er 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

Clinical study 444- it was reported that patient enrolled in a clinical study underwent a left knee procedure on (b)(6) 2015.Subsquently the patient reported episodes of severe to moderate pain with difficulty performing daily activities or using stairs, walking with a limp, and being "housebound" during six months post op visit.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.Please void this submission.

• Brand Name: OXFORD UNI FEMORAL LG
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7338814
• MDR Text Key: 102386152
• Report Number: 0001825034-2018-01627
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 154602
• Device Lot Number: J3341076
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 108