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

Model Number N/A

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Death  

Event Description

Information was received based on review of a journal article titled, "oxford medial unicompartmental knee arthroplasty", which described the outcome of oxford meniscal-bearing unicompartmental arthroplasties carried out for osteoarthritis of the medial compartment, using the oxford knee manufactured at biomet.The study was conducted over a period of sixteen (16) years (1983 to 1999) and involved one-hundred three (103) patients who received one-hundred twenty-four (124) knees.Thirty-seven (37) patients died due to unknown reasons.The journal article reports the following revisions by reason: three (3) revisions due to bearing dislocation.Two (2) revisions due to aseptic loosening.One (1) revision due to infection.The authors of the study conclude that the use of a meniscal-bearing prosthesis can provide good long-term results of unicompartmental replacement, probably by avoiding failure from poly wear.

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.Date of event - unknown; expiration date - unknown; date implanted - unknown; date explanted - unknown; initial reporter - the article was written by svärd uc, price aj in j bone joint surg br.2001 mar;83(2): 191-4; manufacture date ¿ unknown.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information: the following sections were updated: outcomes attributed to adverse event, added additional information, other relevant history, catalog and lot number, patient and device codes, report source, type of reportable event, method, results, and conclusion codes, manufacturer narrative.The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) and complaint history review was unable to be performed as the lot/item 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, under warnings: major surgical risks associated with anesthetic including, brain damage, pneumonia, blood clots, heart attack, and death.Following review, no new risks were identified.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

A review of the article identified thirty-seven (37) patients that died due to unknown reasons.There has been no further information provided.

• 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: 4903261
• MDR Text Key: 6534333
• Report Number: 0001825034-2015-02954
• 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,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

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
• 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: 06/18/2015
• Initial Date FDA Received: 07/09/2015
• Supplement Dates Manufacturer Received: 06/18/2015
• Supplement Dates FDA Received: 10/26/2017
• 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): Death; Hospitalization; Required Intervention