MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH CURVED IMPLANT; TENDON/LIGAMENT BONE ANCHOR, NON-BIOABSORBABLE

Catalog Number 110024773

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 06/17/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: juggerstitch curved implant cat# 110024773 lot# 437050.Foreign source: france.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02838.

Event Description

It was reported that a patient was found to have pain, swelling, and clicking noises approximately 6 months post implantation, as well as a new meniscal tear approximately 1 year post implantation.The patient is scheduled for reoperation, although no procedure has been reported at the time of this report.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.The following sections were updated: b4, b5, g3, g6, h2, h10.

Event Description

It was reported that a patient was found to have pain, swelling, and clicking noises approximately 6 months post implantation, as well as a new meniscal tear approximately 1 year post implantation.The patient was scheduled for reoperation, but this procedure was cancelled as the patient spontaneously healed.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A cfr was provided and reviewed by a health care professional.A timeline was created and review of the available records identified the following: 6-week follow-up--no pain, good range of motion, negative for clicking, constant swelling.6-month follow-up-- moderate pain taking paracetamol, positive for clicking, constant swelling, extremely stiff.A definitive root cause cannot 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.

• Brand Name: JUGGERSTITCH CURVED IMPLANT
• Type of Device: TENDON/LIGAMENT BONE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16052003
• MDR Text Key: 306176778
• Report Number: 0001825034-2022-02837
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K191459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110024773
• Device Lot Number: 985410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 02/16/2023; 04/19/2023
• Supplement Dates FDA Received: 02/20/2023; 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 86 KG