MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL FEMUR CEMENTED; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: (b)(4).Medical product: persona vivacit-e partial articular surface cat#: 42518200508, lot# 63449771.Persona partial tibial cemented cat#: 42538000501, lot# 63463511.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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:0001825034 - 2017 - 10764, 0001825034 - 2017 - 10765, 0001825034 - 2017 - 10766.Remains implanted.

Event Description

It was reported that three weeks after initial knee procedure a patient was experiencing an episode of tendonitis around hamstrings and thigh causing reduced range of motion.Patient was treated with physiotherapy targeted at patella relaxation.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.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.

Manufacturer Narrative

(b)(4).Concomitant medical products: partial articular surface left medial size e 8 mm thickness, lot#63449771, item#42518200508 , persona partial tibial cemented item#42538000501, lot# 63463511, palacos bone cement lot#unk item#unk.The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Compatibility check noted no issues.Review of the complaint history determined that no further action is required.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: PERSONA PARTIAL FEMUR CEMENTED
• 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: 7076567
• MDR Text Key: 93514357
• Report Number: 0001825034-2017-10765
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• 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: 42558000301
• Device Lot Number: 63522281
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2016
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 64