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

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "sports, physical activity and patient-reported outcomes after medial unicompartmental knee arthroplasty in young patients" which aimed to assess the return-to-activity rate and to evaluate the physical activities of patients under the age of 60 following uka in the medial compartment with the oxford mobile bearing prosthesis, manufactured at biomet.The authors hypothesized that patients under the age of 60 are able to achieve a high level of activity following medial mobile bearing uka.This study consisted of 101 patients and 118 knees age 60 or younger at the time of surgery following minimal invasive oxford performed between september 2001 and december 2007.In 116 knees, the indication for surgery was anteromedial osteoarthritis with severe knee pain after failure of all conservative treatment.Two knees were treated for avascular necrosis of the medial femoral condyle.At final follow-up, 3 patients had died of causes unrelated to their knee surgery without having had revision surgery.Two patients were lost to follow-up.A total of five patients had undergone revision surgery.Three had to be excluded because they were revised to total knee.The first patient was revised at 10 months because of persistent pain.The second patient had a bearing exchange for dislocation at 13 months.Although there were no further dislocations, the knee was revised to a total knee at 32 months for pain both at rest and under load.In the third case, revised to tka at 23 months, the patient reported persistent pain under load and instability of the knee during daily living.In all three cases, the reason for persistent pain was unknown.The other two patients required bearing exchange.At final follow-up 8 years after surgery, the first patient reported a clicking noise in his knee during normal walking and a feeling of instability for 4 weeks.A ct scan confirmed fracture of the 3mm mobile bearing and it was exchanged for a 4mm inlay.The second knee was revised for suspected early infection.Lavage and bearing exchange was performed at two weeks postop.The remaining 93 patients and 109 knees were available for review at a mean follow up of 4.4 years.The mean age at surgery was 55 years old.16 patients had pain in replaced joint.4 patients were disappointed with the oxford.The most important finding in this study was that a vast majority of young and active patients following mobile bearing medial uka were able to return to a high level of regular physical activities.

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 walker et al in journal of arthroplasty (2015) http://dx.Doi.Org/10.1016/j.Arth.2015.05.031.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.The following sections were updated: added additional patient information, updated brand name, added patient and device codes, added ¿health professional.¿ added manufacturer narrative (below).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the 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.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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 one (1) patient who was revised at 10 months because of persistent pain to a tka.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: 4924982
• MDR Text Key: 19310381
• Report Number: 0001825034-2015-03076
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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