MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE JUGGERKNOT 2.9 W/ TAPERED NEEDLES; FASTENER, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Nausea (1970); Pain (1994); Swelling (2091); Vomiting (2144); Fluid Discharge (2686); No Code Available (3191)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Product is currently not expected to return to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up medwatch will be submitted.

Event Description

It was reported that the patient underwent a shoulder procedure using an anchor and is experiencing sores on hand, nausea, vomiting, pain, swelling and draining at the incision.Patient has also been indicated for revision due to infection.No revision has occurred to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.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 was reported that the patient underwent a shoulder repair procedure using an anchor and is experiencing sores on hand, nausea, vomiting, pain, swelling and draining at the incision.The patient is now being indicated for revision due to infection.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.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 was reported that the patient underwent a right shoulder arthroscopy procedure with rotator cuff repair utilizing an anchor, and is experiencing sores on hand, nausea, vomiting, pain, swelling and draining at the incision.The patient is now being indicated for revision due to infection approximately two (2) years post-implantation.

Manufacturer Narrative

(b)(4).The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were 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.It is noted in initial op-notes that "the juggerknot suture anchor was placed in the bicipital groove.The proximal end of the biceps tendon stump was amputated.It was suspected that the tenodesis site had a good solid repair of the biceps in the anterior humerus.Investigation identified that this product was in scope of a previous investigation that identified the tyvek seal on the product was potentially weak, which compromised sterility and lead to infection and the reported issue.The root cause was determined to be manufacturing deficiency.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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

No further event information available at the time of this report.

• Brand Name: JUGGERKNOT 2.9 W/ TAPERED NEEDLES
• Type of Device: FASTENER, FIXATION
• 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: 6731955
• MDR Text Key: 80669352
• Report Number: 0001825034-2017-05111
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 110005096
• Device Lot Number: 649620
• Other Device ID Number: (01) 00880304548091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 111