MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE JUGGERKNOT 2.9 TPRD NEEDLES 10PK; FASTENER, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Itching Sensation (1943); Pain (1994); Rash (2033); Weakness (2145); Reaction (2414); Sweating (2444); Weight Changes (2607); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as this is still implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.This report is based on allegations set forth in the patient's complaint and the allegations contained therein are unverified.

Event Description

It is reported that following a shoulder soft tissue repair procedure utilizing juggerknot suture anchors, that the patient began experiencing food and other allergies, red spots and itching sensations on the body, and other unspecified health problems.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 following a shoulder soft tissue repair procedure utilizing juggerknot suture anchors, that the patient began experiencing food allergies, red spots and itching sensations on the body, weakness and fatigue, painful spots on the shoulder, weight loss, and excessive sweating.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).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 unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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.

• Brand Name: JUGGERKNOT 2.9 TPRD NEEDLES 10PK
• 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: 6432201
• MDR Text Key: 70797441
• Report Number: 0001825034-2017-02051
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: PK110145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/22/2017

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 Expiration Date: 02/15/2022
• Device Model Number: N/A
• Device Catalogue Number: 110005242
• Device Lot Number: 153670
• Other Device ID Number: REFERENCE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided; 06/26/2017; 11/17/2017
• Supplement Dates FDA Received: 06/26/2017; 07/26/2017; 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other