MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE EZLOC/ WASHERLOC DISPOSABLE KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Synovitis (2094)

Event Date 12/29/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has not yet indicated if the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-00590/ 0001825034-2017-00591/ 0001825034-2017-02519/ 0001825034-2017-02522/ 0001825034-2017-02525.

Event Description

It is reported that the patient initially underwent arthroscopically assisted anterior cruciate ligament reconstruction in her right knee.Subsequently, the patient underwent a synovectomy procedure approximately seven (7) months post-operatively due to pain and swelling.Revision operative notes provided noted hypertrophic synovial tissue and a "cyclops" lesion.The excess tissue was removed.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional information.Reported event was confirmed through receipt of medical records and operative notes.The notes cover the procedure to remove a "hypertrophic synovial lesion, anterior aspect, right knee" and a "cyclops lesion".The report also notes that "there was no significant degenerative changes" and that the "anterior cruciate ligament graft.Is in good position." no devices were received; therefore the visual inspection was not performed.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.This product is in scope of previous corrective action, however, root cause was unable to be confirmed for this event.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 is reported that the patient initially underwent arthroscopically assisted anterior cruciate ligament reconstruction in her right knee.Subsequently, the patient underwent a synovectomy procedure approximately seven (7) months post-operatively due to pain and swelling.Operative notes provided noted hypertrophic synovial tissue and a "cyclops" lesion.The excess tissue was removed.The surgeon later expressed the possibility of potential infection, however this was not confirmed.

• Brand Name: EZLOC/ WASHERLOC DISPOSABLE KIT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6500279
• MDR Text Key: 73028734
• Report Number: 0001825034-2017-02524
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 909836
• Device Lot Number: 529190
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1827-2016
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR