MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXFORD PH3 CEMENTLESS FEM SZ M; KNEE PROSTHESIS

Model Number N/A

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

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 06/17/2008

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Reported event was unable to be confirmed as 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.Zimmer biomet complaint number: (b)(4).Hooper, g.J.Et al.J bone joint surg br 2012;94-b:334¿8.See attachments - attachment: [the early radiological results of the uncemented oxford medial compartment knee replacement.

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 one patient who underwent left partial knee arthroplasty on (b)(6) 2007.Subsequently, patient was revised to a total knee on (b)(6) 2008 due to lateral compartment osteotomy.Patient was revised to a total knee.No further information has been provided.

• Brand Name: OXFORD PH3 CEMENTLESS FEM SZ M
• Type of Device: KNEE PROSTHESIS
• 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: 6910406
• MDR Text Key: 88010418
• Report Number: 0001825034-2017-07806
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: PN/A
• 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: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• 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: 154926
• Device Lot Number: N/A
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR