MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH CURVED IMPLANT; FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE

Catalog Number 110024773

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Unspecified Tissue Injury (4559)

Event Date 06/07/2023

Event Type  Injury  

Event Description

It was reported that the patient had an initial anterior cruciate ligament reconstruction and a medial meniscus repair approximately eight (8) months ago.Six (6) months later the patient began jogging and developed moderate pain ten days after starting to jog.Subsequently, the patient underwent a partial meniscectomy approximately two (2) months ago where it was determined that one of the implants had fractured.A small inner rim tear at the junction of mid body and posterior horn of the meniscus was found.

Manufacturer Narrative

(b)(4).D10: medical products: item#: 110024773, juggerstitch curved implant; lot#: 190220.Item#: 110024773, juggerstitch curved implant; lot#: 190220.Item#: 110024773, juggerstitch curved implant; lot#: 190220.Item#: 110024773, juggerstitch curved implant; lot#: 190220.Item#: 110024773, juggerstitch curved implant; lot#: 190220.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.The investigation remains in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial anterior cruciate ligament (acl) tear reconstruction and medial meniscus repair approximately ten (10) months ago.Subsequently, five months post-operative, the patient developed an onset of pain after running.The patient underwent a partial medial meniscectomy a month later and found a large effusion with limited range of motion, synovitis, a fractured implant, and a small inner rim tear at the junction of the posterior horn and medial meniscus.The fractured implant was removed, and no intra-op complications or events were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: the following section was corrected: 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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: (b)(6) 2023, ae (pg 21): patient was jogging, progressive moderate pain followed 10 days after.Partial meniscectomy due to meniscal tear.- july 26, 2023, surgery op notes.Pdf (3 pgs.): presented 5 months after surgery with onset of pain after running.Partial medial meniscectomy with removal of a broken suture.Loose suture in the medial compartment and removed ¿in the area of the tear, there were 2 soft implants that came in contact with surface of the tibial plateau¿ removed.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.

Event Description

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

• Brand Name: JUGGERSTITCH CURVED IMPLANT
• Type of Device: FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE
• 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: 17638178
• MDR Text Key: 322135571
• Report Number: 0001825034-2023-02025
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00880304690073
• UDI-Public: (01)00880304690073(17)270830(10)190220
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• 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: 190220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 70 KG