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

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Streit, m.R., streit, j., walker, t., bruckner, t., kretzer, j.P., ewerbeck, v.,.Gotterbarm, t.(2015, may 10).Minimally invasive oxford medial unicompartmental knee arthroplasty in young patients.Retrieved october 20, 2017/10.1007/s00167-015-3620-x.The product was not available for return.Without the opportunity to examine the complaint device, root cause cannot be determined.Condition is addressed in the package insert.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.

Event Description

Information was received based on review of a journal article titled, "minimally invasive oxford medial unicompartmental knee arthroplasty in young patients".A patient was identified in the article that underwent an arthroscopic procedure due to persistent pain in which a lateral meniscal tear was found at fifty-six (56) months post initial oxford medial unicompartmental knee arthroplasty on unknown dates.It was reported that the patient did well.

• 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: 6968112
• MDR Text Key: 89926200
• Report Number: 0001825034-2017-09465
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• 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: 06/26/2015
• 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