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

Model Number N/A

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

Patient Problems Death (1802); Staphylococcus Aureus (2058)

Event Type  Death  

Event Description

J bone joint surg br 2012; 94-b: 1356-61 doi: 10.1302/0301-620x.94b10 streit, m.R., et al.Information was received based on review of a journal article titled, "mobile-bearing lateral unicompartmental knee replacement with the oxford domed tibial component" which aimed to provide short-term results after a minimum follow-up of two years using the oxford domed lateral ukr manufactured at biomet.The study was conducted over a period of two (2) years (december 2006 and march 2009) and involved fifty (50) patients who received fifty (50) knees.The journal article reports the following manipulation by reason: one (1) bearing repositioning due to medial subluxation of the bearing the journal article reports the following revisions by reason: one (1) revision due bearing subluxation, one (1) revision due to anterior dislocation, one (1) revision due to (b)(6) infection.The authors of this study conclude that clinical results are excellent and short-term survival has improved when compared with earlier series.The risk of dislocation remains higher using a mobile-bearing ukr in the lateral compartment when compared with the medial compartment.Patients should be informed about this complication.To avoid dislocations, care must be taken not to elevate the lateral joint line.

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 article was written by streit mr, et al in j bone joint surg br.2012 oct;94(10):1356-61.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).This supplemental report is being submitted to address only one event of the article.The following fields have been updated with additional/ updated information.Added death, added additional information, added brand name, added patient and device codes, added health professional, added method, results, and conclusion codes, added additional manufacturer narrative.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.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

One patient was identified in the article who died due to unknown reason on an unknown date.There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN OXFORD PARTIAL 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: 4945771
• MDR Text Key: 18638793
• Report Number: 0001825034-2015-03334
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• 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
• 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: 08/10/2017
• 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