MAUDE Adverse Event Report: BIOMET UK LTD UNKNOWN KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Type  Injury  

Event Description

Information was received based on review of a journal article entitled, "minimally invasive oxford phase 3 unicompartmental knee replacement." this prospective study describes the outcome of the first 1000 phase 3 oxford medial unicompartmental knee replacements implanted using a minimally invasive surgical approach for the recommended indications by two surgeons and followed up independently.The mean follow-up was 5.6 years (1 to 11) with 547 knees having a minimum follow-up of five years.The study was conducted between june 1998 and march 2009, 97 knees received a medial oxford unicompartmental knee replacement for indications that are not recommended.These 97 patients were not included in the study.During the study, 63 patients (72 knees) died.No patients died as a result of their surgery, but of unrelated causes.The journal article reports that 29 revision procedures occurred due to the following reasons: 6 revisions due to bearing dislocations, 3 revisions due to infections, 6 revisions due to pain, 4 revisions due to pain and swelling, 9 revisions due to lateral compartment osteoarthritis, 1 revisions due to loose tibial component.This study demonstrates that, when used for appropriate patients, minimally invasive mobile-bearing unicompartmental knee replacement is safe and effective.

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 h pandit in bone joint surg (br} 2011;93-8:198¿204.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

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Product location unknown.

Event Description

Information was received based on review of a journal article entitled, "minimally invasive oxford phase 3 unicompartmental knee replacement." this prospective study describes the outcome of the first 1000 phase 3 oxford medial unicompartmental knee replacements implanted using a minimally invasive surgical approach for the recommended indications by two surgeons and followed up independently.The mean follow-up was 5.6 years (1 to 11) with 547 knees having a minimum follow-up of five years.The study was conducted between june 1998 and march 2009, 97 knees received a medial oxford unicompartmental knee replacement for indications that are not recommended.These 97 patients were not included in the study.During the study, 63 patients (72 knees) died.No patients died as a result of their surgery, but of unrelated causes.The journal article reports that 29 revision procedures occurred due to the following reasons: 6 revisions due to bearing dislocations; 3 revisions due to infections; 6 revisions due to pain; 4 revisions due to pain and swelling; 9 revisions due to lateral compartment osteoarthritis; 1 revisions due to loose tibial component.This study demonstrates that, when used for appropriate patients, minimally invasive mobile-bearing unicompartmental knee replacement is safe and effective.Additional information received based on a review of a follow up journal article entitled, "the clinical outcome of minimally invasive phase 3 oxford unicompartmental knee arthroplasty." the journal article reports a total of 52 revision procedures occurred due to the following reasons: 7 revisions due to bearing dislocations; 5 revisions due to infection; 7 revisions due to unexplained pain; 1 revision due to avascular necrosis of lateral femoral condyle; 1 revision due to tibial malposition; 25 revisions due to lateral compartment osteoarthritis; 1 revision due to infection following acl reconstruction for traumatic rupture; 1 revision due to aseptic loosening of femoral component; 1 revision due to aseptic loosening of tibial component; 1 revision due to instability; 1 revision due to unknown; 1 revision due to acl injury.

• Brand Name: UNKNOWN KNEE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterlon industrial estate; bridend, south wales
• 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: 4799537
• MDR Text Key: 5917929
• Report Number: 0001825034-2015-02246
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2016
• 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): Required Intervention