MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA UNI INSTRUMENTS; KNEE INSTRUMENT

Model Number N/A

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.The root cause of the reported issue is attributed to a design deficiency.The root cause of the reported issue is attributed to a design deficiency.

Event Description

It was reported that during a left medial unicompartmental arthroplasty with the zimmer ppk system, the surgeon felt the flexion gap is too tight.He mentioned that the tightness has left him concerned about the survivorship for that patient.

• Brand Name: PERSONA UNI INSTRUMENTS
• Type of Device: KNEE INSTRUMENT
• 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: 7170705
• MDR Text Key: 96709637
• Report Number: 0001825034-2018-00134
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42578100801
• Device Lot Number: 63518668
• Other Device ID Number: (01)00880304809253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z2017-258
• Patient Sequence Number: 1
• Patient Weight: 93