MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD TIBIAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Zachary c.Lum, david a.Crawford, adolph v.Lombardi jr., jason m.Hurst, michael j.Morris b,d, joanne b.Adams, keith r.Berend: early comparative outcomes of unicompartmental and total knee arthroplasty in severely obese patients https://doi.Org/10.1016/j.Knee.2017.10.006.Device remains implanted.As limited information was received from the customer, the reported events could not be confirmed.As the lot numbers of the devices are unknown, dhr reviews could not be performed.Root cause could not be determined.If further information is found that would change or alter any conclusions reached, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor trends.

Event Description

Information received based on review of a journal article, entitled "early comparative outcomes of unicompartmental and total knee arthroplasty in severely obese patients" abstract background: medial unicompartmental knee arthroplasty (uka) may have advantages overtotal knee arthroplasty (tka) in the setting of obesity.There has been no direct comparison between the two cohorts.This study compares outcomes and complications of severely obese patients undergoing medial uka versus tka.Methods: six hundred and fifty medial uka and 1300 tka were performed in patients with bmi n35 kg/m2 (mean 41 kg/m2) between 2007 and 2012.Pre- and postoperative rom, knee society scores, perioperative factors, complications and reoperations were compared.Results: uka patients had higher preoperative rom, and knee society pain (ksp), functional (ksf), and clinical (ksc) scores (p b 0.001, p = 0.0008, p = 0.0003, p = 0.051 respectively).Mean tourniquet times, operative times, and lengths of stay were lower after uka.Four tka.Patients required transfusion.Mean follow-up was 2.3 years.The frequency of manipulation under anesthesia was higher in tka patients (p b 0.001), while the rate of component revision was similar between the two groups (1.2% vs.1.7%, p = 0.328).Frequency of deep infection was lower in the uka group (p = 0.016).Postoperative ksf, change in ksf, and rom were higher (p b 0.0001) after uka, but ksp and ksc were equivalent.Conclusions: severely obese patients who underwent medial uka demonstrated equal survivorship with substantially fewer reoperations, reduced deep infection, and less perioperative complications at short term follow-up.Severely obese patients had improved ksf scores and maintenance of rom after uka compared with tka this complaint refers to irrigation & debridement of a non-healing wound following uka arthroplasty procedures stated on page 163.

• Brand Name: UNKNOWN OXFORD TIBIAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7341455
• MDR Text Key: 102515084
• Report Number: 3002806535-2018-00470
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2018
• 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