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

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problems Arthritis (1723); Bone Fracture(s) (1870); No Code Available (3191)

Event Type  Injury  

Event Description

Information was received based on review of a journal article entitled, "medial unicompartmental arthroplasty of the knee." which aimed to asses the outcomes of unicompartmental arthroplasties.The study was conducted over a period of eleven (11) years (january 1985 and january 1996) and involved one-hundred (100) knees.The journal article reports the following revisions by reason: four (4) revisions due to loosening, two (2) revisions due to progressive arthritis, one (1) revision due to fracture of the medial tibial plateau.The authors of the study conclude that medial compartment knee arthroplasty provides satisfactory treatment in the elderly patient, although attention must be directed to technical aspects and patient selection, to afford long-term success.

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).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 supplemental report is being submitted to address only one event of the article.The following fields have been updated with additional/ updated information.Event type, event or problem, brand name, catalog and lot number, patient and device codes, report source, device evaluated by manufacturer, 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.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation, under possible adverse effects: " loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ and " fatigue fracture of components can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.¿ following review, no new risks were identified.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.(b)(4).This report is being submitted late as it has been identified in remediation.

Event Description

Information was received based on review of a journal article entitled, "medial unicompartmental arthroplasty of the knee." this report addresses the (4) unidentified patients that were revised due to loosening and a fracture of the medial tibial plateau.There has no further information provided and the patients outcome is unknown.

• Brand Name: UNKNOWN OXFORD 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: 4936630
• MDR Text Key: 6037626
• Report Number: 0001825034-2015-03064
• 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,Literature,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 06/16/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention