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

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems Arthritis (1723); Pain (1994); Fluid Discharge (2686); No Information (3190)

Event Type  Injury  

Event Description

Information was received based on review of a journal article entitled, "unicompartmental knee arthroplasty with the oxford prosthesis in patients with medial compartment arthritis" which determined the limb alignment achieved in the absence of ligament release and to investigate the interplay of failure mode, survivorship, and limb alignment.The study was conducted over a period of five (5) years (1989 to 1994) and involved fifty-one (51) patients who received fifty-five (55) knees.Two (2) patients (three (3) knees) were lost to follow-up.The journal article reports the following revisions by reason: five (5) revisions due to arthritis to total knee.One (1) revision due to femoral component loosening to total knee.One (1) revision due to osseous impingement in full extension, causing pain and effusion with bearing replacement.The authors of the study conclude that with this unicompartmental knee arthroplasty, the mechanical limb alignment resulting from balancing the knee ligaments, accomplished without releasing them, was consistently through the center of the knee.Progression of arthritis in the lateral compartment was the most common reason for late failure in this series and was not related to the initial postoperative alignment.

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.Initial reporter - the article was written by emerson rh jr, higgins ll in j bone joint surg am.2008 jan;90(1):118-22.Doi: 10.2106/jbjs.F.00739.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

(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.Emerson, roger h.¿unicompartmental knee arthroplasty with the oxford prosthesis in patients with medial compartment arthritis.¿ the journal of bone and joint surgery, incorporated, vol.90, 2008, pp.118¿122.(b)(4).

Event Description

Revisions due to osseous impingement.

• 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: 4925680
• MDR Text Key: 6054700
• Report Number: 0001825034-2015-03121
• 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: Literature,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• 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: 06/25/2015
• 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