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

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); No Code Available (3191)

Event Type  Death  

Event Description

Information was received based on review of a journal article titled, "long-term clinical results of the medial oxford unicompartmental knee arthroplasty", which aimed to document the 15-year survival and 10-year clinical and radiologic results of the device in a large independent series.The study was conducted over a period of seventeen (17) years (1983 to 2000) and involved three-hundred fifty-one (351) patients who received four-hundred thirty-nine (439) knees.Sixty (60) patients, seventy-six (76), knees died due to unknown reasons.The journal article reports the following revisions by reason: seven (7) revisions due to arthritis in the lateral compartment, five (5) revisions due to dislocations, one (1) revision due to dislocation and femoral component loosening, two (2) revisions due to femoral and tibial component loosening, three (3) revisions due to femoral component loosening, two (2) revisions due to deep infection, one (1) revision due to meniscus fracture, two (2) revisions due to unexplained pain.The authors of the study conclude that the results show that an independent center can achieve excellent long-term clinical and survival results in patients implanted with the oxford prosthesis.Survival of the implant was not reduced by the use of thin polyethylene bearings.

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 price aj, waite jc, svard u in clin orthop relat res.2005 jun;(435):171-80.Manufacture date ¿ unknown.

Manufacturer Narrative

This supplemental report is being submitted to address only one event of the article.The following fields have been updated and corrected with additional/ updated information.Outcomes attributed to adverse event, event or problem, brand name, catalog and lot number, patient and device codes, report source, type of reportable event, device evaluated by manufacturer, method, results, and conclusion codes, manufacturer narrative.The following section was corrected: initial reporter: telephone number.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.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

Information was received based on review of a journal article titled, "long-term clinical results of the medial oxford unicompartmental knee arthroplasty" this report addresses the sixty-eight (68) patients that died due to unknown causes.There has been no further information provided.

• Brand Name: UNKNOWN OXFORD 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: 4917977
• MDR Text Key: 6029640
• Report Number: 0001825034-2015-03016
• 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: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• 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: 06/26/2017
• Was Device Evaluated by Manufacturer?: No
• 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