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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation due to unknown location.Due to lack of item and lot numbers review of device history, complaint history, manufacturing, and deviations could not be performed.The root cause could not be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.There are warnings in the package insert, under possible adverse effects, number 10 states, ¿loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ number 13 states, ¿dislocation and subluxation due to inadequate fixation and improper positioning.¿ following review, no new risks were identified.Literature: craik johnathan d., el shafie sherif, singh vinay kumar, twyman roy s., revision of unicompartmental knee arthroplasty versus primary total knee arthroplasty, journal of arthroplasty (2014), doi:10.1016/j.Arth.2014.10.038.(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2014-09078; 0001825034-2017-08033/08035/08038 - (b)(4).Product location unknown.

Event Description

Information was received based on review of a journal article titled, "revision of unicompartmental knee arthroplasty versus primary total knee arthroplasty" two (2) unknown patients were identified in the article that underwent revisions due to poly-dislocation.There has been no further information provided and the patient outcome is unknown.Attempts have been made and no further information has been provided.

• Brand Name: UNK 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: 6926053
• MDR Text Key: 88913862
• Report Number: 0001825034-2017-08037
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• 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 KNEE
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2014
• 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): Hospitalization; Required Intervention