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

Model Number N/A

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Necrosis (1971); Pain (1994)

Event Type  Death  

Event Description

Information was received based on review of a journal article titled, "comparison of outcomes after uka in patients with and without chondrocalcinosis: a matched cohort study" which aimed to report the outcome of a consecutive series of patients with chondrocalcinosis and medial compartment osteoarthritis treated with uka matched to controls, using the oxford.The study consisted of 1013 cemented phase 3 medial oxford uka's implanted between 1998 and 2008.123 had either radiological (r-cck) or histological (h-cck) evidence of chondrocalcinosis and 31 knees had both histological and radiological chondrocalcinosis.Each patient with chondrocalcinosis was matched to 2 controls using an algorithm.The mean follow-up was 10 years.Nine out of 123 knees with chondrocalcinosis underwent revision.Six out of 67 knees were in the h-cck group, 3 out of 87 knees were in the r-cck group, and 2 out of 31 knees had both histological and radiographical evidence of chondrocalcinosis.Four out of 246 knees in the control group underwent a revision.Of the six knees in the histological chondrocalcinosis group that underwent revision, one knee was revised for lateral compartment oa.The other five knees with chondrocalcinosis were revised due to aseptic loosening in one knee, bearing dislocation in two knees, persistent pain in one knee, and lateral avn in one knee.In the 87 knees with radiological chondrocalcinosis, three knees underwent revision for persistent pain, bearing dislocation, and avascular necrosis of lateral femoral condyle leading to secondary oa.In conclusion, the presence of r-cck does not influence functional outcome or survival following uka.Pre-operative radiological evidence of cck should not be considered to be a contraindication to uka.H-cck is associated with significantly improved clinical outcomes but also a higher revision rate compared with controls.

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patients mentioned in the journal article.(b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information: the following sections were updated: outcomes attributed to adverse event.Added additional information.Catalog and lot number.Patient and device codes.Type of reportable event.Method, results, and conclusion codes.Manufacturer narrative.The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) and complaint history review was unable to be performed as the lot/item 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.This report is being submitted late as it has been identified in remediation.

Event Description

A review of the article identified an unknown number of patient deaths.There has been no further information provided.

• Brand Name: UNKNOWN KNEE
• 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: 4799884
• MDR Text Key: 5921324
• Report Number: 0001825034-2015-02270
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• 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
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• 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; Hospitalization; Required Intervention