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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Lewold, s., robertsson, o., knutson, k., & lidgren, l.(1998).Revision of unicompartmental knee arthroplasty: outcome in 1, 135 cases from the swedish knee arthroplasty study.Acta orthopaedica scandinavica, 69(5), 469-474.Doi:10.3109/17453679808997780.The product was not available for return.Without the opportunity to examine the complaint device, root cause cannot be determined.Part and lot identification are necessary for review of device history records and complaint history, neither were 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.(b)(6).

Event Description

Information was received based on review of a journal article entitled, "revision of unicompartmental knee arthroplasty.Outcome in 1,135 cases from the swedish knee arthroplasty study".The study was conducted over a period of twenty(10) years (1975-1995) and involved fourteen-thousand seven-hundred seventy-two (14,772) ukas, of which nine-hundred eighty-three (983) were oxford biomet ukas.This complaint pertains to an unknown number of patients who were identified in the article that underwent revision due to subsidence.There has been no further information provided and the patient(s) 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: 7038496
• MDR Text Key: 92281160
• Report Number: 0001825034-2017-10326
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2015
• 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): Hospitalization; Required Intervention