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

Model Number N/A

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Arthritis (1723); Death (1802); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Type  Death  

Event Description

Information was received based on review of a journal article titled, "mid-term results of oxford phase 3 unicompartmental knee arthroplasties (uka) at a small-volume center" which aimed to find out clinical and radiological outcomes and related complications using the oxford phase 3 prosthesis at a small-volume center.The study was conducted over a 10 year period (2000-2010) and involved surgery on 87 patients and 95 oxford knees.In all, 52 knee arthroplasties participated in the study.Within the article, there were five noted revisions: two as a result of progression of knee osteoarthritis, one as a result of component malalignment, one as a result of implant loosening, one as a result of dislocation.There were also twelve other minor problems noted that did not result in a revision procedure: one due to superficial infection, nine due to pain, one pulmonary embolism, and one loose bony bodies that were removed by arthroscopy.Additionally, seven patients have died due to unknown reasons during the follow up.The authors of this study conclude that uka surgeries should be focused to well-trained orthopedic surgeons to achieve better results.

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)(6).It is likely that these complications and revisions have already been reported; however, it cannot be determined based on the limited information made available in the article.Should additional information relating to the events be received, the updated information will be forwarded to the fda.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).Reported event was unable to be confirmed as part number and lot number of the device involved in the incident is unknown.Device history record 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.This report is being submitted late as it has been identified in remediation.Miettinen, s.S.A.¿mid-term results of oxford phase 3 unicompartmental knee arthroplasties at a small-volume center.¿ scandinavian journal of surgery, 2015, pp.1¿8.(b)(4).

Event Description

Seven (7) unknown deaths during the follow up time.

• 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: 4782175
• MDR Text Key: 5856582
• Report Number: 0001825034-2015-02039
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• 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 KNEE
• 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