MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Unspecified Infection (1930); Pain (1994)

Event Type  Death  

Event Description

Information was received based on review of a journal article titled, "a second lifetable survival analysis of the oxford unicompartmental knee arthroplasty" which reports the 20-year survivorship for the oxford mobile bearing medial unicompartmental knee arthroplasty; reasons for the revisions; and time to revision, using the oxford implant manufactured at biomet.This study consists of five-hundred forty-three (543) patients who underwent six-hundred eighty-two (682) medial oxford meniscal bearing unicompartmental knee arthroplasties conducted over a period of twenty-two (22) years (1983 to january 2005).One hundred-forty one patients (172 knees) died and twenty-nine (29) revisions occurred.The journal article reports the following revisions by reason: ten (10) revisions due to lateral arthrosis.Nine (9) revisions due to component loosening.Five (5) revisions due to infection.Two (2) revisions due to bearing dislocations.Three (3) revisions due to pain.The journal article reports the following bearing exchanges by reason: four (4) due to dislocation.One (1) due to bearing fracture.The authors of the study conclude that mobile bearing unicompartmental knee arthroplasty is durable during the second decade after implantation.

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.(b)(4).

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section was corrected: corrected from serious injury to death.The following sections were updated: added "death", added additional information, added patient and device codes, added health professional.Added method, results, and conclusion codes.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) and complaint history review was unable to be performed as the part and 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.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.

Event Description

This report has been submitted for the patient deaths.The article identified that during the study period of twenty-two (22) years (1983 to january 2005), one hundred forty-one patients died (reasons unknown).There has been no further information provided.

• Brand Name: UNKNOWN KNEE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 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: 4903238
• MDR Text Key: 6070742
• Report Number: 0001825034-2015-02952
• 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,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• 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: 06/18/2015
• 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): Death; Hospitalization; Required Intervention