MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT 1.4MM 1 #1 MB 10PK; FASTENER, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Cyst(s) (1800)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, remains implanted.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: 0001825034-2019-01066.

Event Description

It was reported that the patient had underwent a open rotator cuff repair with subacromial debridement on the right shoulder, and subsequently the patient experienced cystic changes approximately six (6) years post implantation.No additional information is available.

Event Description

No additional information is available to report at this time.

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

The following report is being submitted to report additional information received: the reported event is confirmed based on the operative records that were provided stating per radiology report the lack of contrast media, the slightly sclerotic limiting the cyst and the association with the suture anchor is may be due to cystic changes / ganglia due to the suture anchors.Review of the device history records identified no deviations or anomalies during manufacturing.Root cause could not be determined.It is noted that the patient experienced a trauma to the shoulder which may have been a contributing factor.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information is available to report at this time.

• Brand Name: JUGGERKNOT 1.4MM 1 #1 MB 10PK
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8408700
• MDR Text Key: 138410371
• Report Number: 0001825034-2019-01065
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K071704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 912010
• Device Lot Number: 967420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN JUGGER KNOT; UNKNOWN JUGGER KNOT
• Patient Outcome(s): Other