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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Scar Tissue (2060); Patient Problem/Medical Problem (2688); Fibrosis (3167)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "an algorithm for the posterior cruciate ligament in total knee arthroplasty¿ which compared one-hundred seventy-one (171) maxim cr (cruciate-retaining) knees and one-hundred eighty (180) maxim ps (posterior-stabilized) knees.No statistically significant differences in outcome between the groups were observed.The journal article reports that six (6) revision procedures in the group that received maxim cr knees occurred due to the following reasons: one (1) revision with arthrotomy and polyethylene tibial component exchange, one (1) revision where irrigation and debridement was performed, one (1) revision for lateral retinacular release and peripatellar scar excision, one (1) revision of the femoral component due to flexion contracture, secondary to tight posterior cruciate ligament (pcl), one (1) revision due to arthrofibrosis, one (1) revision due to peri-prosthetic femoral fracture.The journal article reports that eleven (11) revision procedures in the group that received maxim ps knees occurred due to the following reasons: two (2) revisions with arthrotomy and polyethylene tibial component exchange, one (1) revision where irrigation and debridement was performed, two (2) revisions for lateral retinacular release, three (3) revisions where radical debridement was performed, one (1) revision of tibial component due to dislocation secondary to a fall, one (1) revision due to peri-prosthetic femoral fracture, one (1) revision due to ligamentous instability with history of dislocation.The authors of the study conclude ¿the use of a standardized algorithm has streamlined the treatment of patients having primary total knee arthroplasty, consistently providing excellent clinical results when either retaining or sacrificing the posterior cruciate ligament.¿.

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.The following sections could not be completed with the limited information provided.The article was written by adolph v.Lombardi, jr., md et al, clinical orthopaedics and related research number 392, pp.75¿87; 2001 lippincott williams & wilkins, inc.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.This report is to address only one event of the article.Complaint description, patient/ device codes, evaluation codes, manufacturer narrative.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause is 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.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, "an algorithm for the posterior cruciate ligament in total knee arthroplasty¿ which compared one-hundred seventy-one (171) maxim cr (cruciate-retaining) knees and one-hundred eighty (180) maxim ps (posterior-stabilized) knees.No statistically significant differences in outcome between the groups were observed.This parent complaint addresses the, one (1) revision with arthrotomy and polyethylene tibial component exchange.There has been no further information provided and the patient outcome is unknown.

• 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: 4174923
• MDR Text Key: 5157204
• Report Number: 0001825034-2014-08059
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/15/2014
• Supplement Dates Manufacturer Received: 09/16/2014
• Supplement Dates FDA Received: 10/24/2017
• 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