MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF ANAT BRG RT LG SIZE 3 PMA

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tingling (2171)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device evaluation is not performed as the product has not returned and lot number is unknown.This report is being submitted late as it has been identified in remediation.Reported event was unable to be confirmed as the lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.

Event Description

It was reported that patient underwent a right partial knee arthroplasty on (b)(6) 2007.Subsequently, patient reported left hip pain and tibial hypersensitivity lateral to the scar on the right knee on (b)(6) 2008, a heart attack and ongoing shortness of breath on (b)(6) 2008, right hip pain on (b)(6) 2009 which was resolved by unknown methods on (b)(6) 2015, difficulty kneeling and refusal to do so in case knee "goes wrong" on (b)(6) 2009 and ongoing on (b)(6) 2015, numbness/tingling patch down lateral aspect of shin on (b)(6) 2009 and ongoing on (b)(6) 2012, a small transient ischemic attach requiring a stent in the heart and ongoing cardiac problems on (b)(6) 2012, limited mobility caused by cardiac problems and shortness of breath on (b)(6) 2012, unspecified arthritic rheumatism, spinal problems, and an aneurysm on (b)(6) 2015.No revision procedure has been reported.No further information has been provided.No additional patient consequences were reported.

• Brand Name: OXF ANAT BRG RT LG SIZE 3 PMA
• 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: 6964911
• MDR Text Key: 89844768
• Report Number: 0001825034-2017-09391
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 159582
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability
• Patient Weight: 86