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

Model Number N/A

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Iatrogenic Source (2498)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "the cemented twin-peg oxford partial knee replacement survivorship: a cohort study" in which the aim of the study was to report the longer-term implant survivorship and clinical outcome of the cemented twin-peg oxford partial knee in a patient cohort which includes the original group of 100 patients, treated between 2003 and 2005, plus those treated until the end of 2009.The oxford was manufactured at biomet.This study consisted of 288 medial cemented implants, inserted in 249 patients of which 210 were unilateral and 39 were bilateral.The mean age at the time of operation was 67 years old and the follow-rate of the study was 99.6%.Five patients were revised.There were no cases of dislocation of the bearing, no femoral loosening, and no deep infections.One patient had complications of iatrogenic complete medial collateral division during the tibial cut due to misplacement of the medial retractor.The ligament was repaired, but during a period in a varus cast, the tibial plateau fractured.The fracture healed, and although the patient was very disappointed, it has not led to a revision.In addition, five patients were not very pleased, and five patients were disappointed with the oxford prosthesis.In conclusion, the twin-peg implant can offer secure femoral fixation, and a high degree of sustained clinical benefit and patient satisfaction.

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 white et al in the knee 22 (2015) 333-337 http://dx.Doi.Ogrg/10.1016/j.Knee.2015.03.011.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 report is being submitted late as it has been identified in remediation.This follow-up report is being submitted to relay additional information.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

This report addresses tne patient identified in the article who had had complications of iatrogenic complete medial collateral division during the tibial cut due to misplacement of the medial retractor 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: 4924986
• MDR Text Key: 6014221
• Report Number: 0001825034-2015-03074
• 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: 10/27/2017

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: 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
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 07/20/2015
• Supplement Dates Manufacturer Received: 07/19/2017
• Supplement Dates FDA Received: 10/27/2017
• 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