MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN KNEE; SEE H10

Model Number N/A

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

Patient Problem Death (1802)

Event Date 01/30/2006

Event Type  Death  

Manufacturer Narrative

(b)(6).Reported event was unable to be confirmed as part number / 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.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.Multiple mdr reports were filed for this event, please see associated reports: 1825034 ¿ 2017 ¿ 07907 / 07975 / 07977 / 07979 / 07980.Hooper, g.J.Et al.J bone joint surg br 2012;94-b:334¿8.Product location unknown.

Event Description

Information was received based on review of a journal article entitled, "the early radiological results of the uncemented oxford medial compartment knee replacement." this study consisted of a patient who underwent left partial knee arthroplasty on (b)(6) 2006 and right partial knee arthroplasty on (b)(6) 2006.Subsequently, patient expired on (b)(6) 2009 due to unknown reasons.It was reported that at last follow-up, the patient had well-functioning implants.No further information has been provided.

• Brand Name: UNKNOWN KNEE
• Type of Device: SEE H10
• 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: 6915581
• MDR Text Key: 88210912
• Report Number: 0001825034-2017-07976
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• 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: UNKNOWN KNEE
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• 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): Death
• Patient Age: 74 YR