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

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Scratched Material (3020)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, " in vivo roughening of retrieved total knee arthroplasty femoral components¿ which investigated surface roughness of knee femoral cocr components retrieved after revision for aseptic or septic loosening in order to describe the extent of femoral scratching.Fourteen explanted femoral components were retrieved and roughness measurements were recorded.Four unimplanted biomet agc cocr knee replacement components served as controls.The journal article indicates that only one (1) of the fourteen explanted components was manufactured by biomet.The reason for the revision was not provided.The authors of the study concluded that there was a small but statistically significant roughening of femoral components in vivo compared to controls.This may have important implications for aseptic loosening of knee arthroplasty components and the decision to use scratch resistant components.

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.Brand name - unknown.Catalog number, lot number and expiration date - unknown.Date implanted - unknown.Date explanted - unknown.Initial reporter - the article was written by raphael malikian et al; the knee 21 (2014) 278¿282.510k number - unknown.Manufacture date ¿ unknown.

• Brand Name: UNKNOWN OXFORD KNEE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4178584
• MDR Text Key: 5162511
• Report Number: 0001825034-2014-08112
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• 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
• Date Manufacturer Received: 09/17/2014
• 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