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

Model Number N/A

Device Problems Device Slipped (1584); Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Bone Fracture(s) (1870); Joint Dislocation (2374)

Event Type  Death  

Event Description

Knee surg sports traumatol arthrosc (2006) 14: 40-45 doi: 10.1007/s00167-005-0621-1 vorlat, p.Et al.Information was received based on review of a journal article titled, "the oxford unicompartmental knee prosthesis: an independent 10-year survival analysis" which aimed to provide long-term follow-up of 149 cases using the oxford unicompartmental prosthesis manufactured at biomet.The study was conducted over a period of eight (8) years (1988 to 1996) and involved one-hundred forty (140) patients who received one-hundred forty-nine (149) knees.The journal article reports the following revisions by reason: four (4) revisions due to unknown reason, eight (8) revisions due to lateral progression, one (1) revision due to valgus postop and loose tibia, one (1) revision due to valgus postop and loose femur, one (1) revision due to loose femur, three (3) revisions due to loose tibia, one (1) revision due to instability, four (4) revisions due to dislocated meniscus, one (1) revision due to tibial subsidence, one (1) revision due to valgus postop and lateral progression, two (2) revisions due to fractured meniscus, the authors of this study conclude that in spite of the low survival rate in the present series as compared to that of tka, the indications for an oukp are to be found in the group of patients in whom a revision procedure is likely given their relatively young age.In the light of a 15-year survival rate of tkas between 87percent and 99 percent and a mean life expectancy of 18.42 years at the age of 65 in the belgian population, the authors tend to draw the line at 65 years of age [19, 24, 27, 29, 34].

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.Initial reporter - the article was written by vorlat p, et al in knee surg sports traumatol arthrosc.2006 jan;14(1):40-5.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.Patient identifiers, death, event description, brand name, added patient and device codes, added health professional, death, 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

It was identified that twenty-eight patients died after a mean of sixty-seven (67) months with the prosthesis in place.The cause of death is unknown; however, none of the patients underwent a revision surgery.

• 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: 4943590
• MDR Text Key: 6634312
• Report Number: 0001825034-2015-03285
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 07/27/2015
• 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: 08/09/2017
• 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