MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 2.9MM #2 BLUE MB SNGL; FASTENER, FIXATION

Model Number N/A

Device Problems Fracture (1260); Difficult to Insert (1316); Difficult To Position (1467); Device Difficult to Setup or Prepare (1487); Fitting Problem (2183); Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Muscle Weakness (1967)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation; hospital discarded as biohazard.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under possible adverse effects: under possible adverse effects: improper selection, placement, positioning, and fixation of the device can lead to failure of the device or the procedure.The surgeon is to be familiar with the device, the method of application and the surgical procedure prior to performing surgery.The surgeon must select a type or types of internal fixation devices appropriate for treatment.Dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.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.Multiple mdr reports were filed for this event, please see associated reports: 1825034 ¿ 2017 ¿ 09215 / 09217.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that the patient underwent right total hip arthroplasty on (b)(6) 2015 at which time a bipolar hip was implanted.Subsequently, the patient was revised on (b)(6) 2015 due to dislocation as result of loose abductor muscles and a greater trochanteric fracture.During the procedure, the surgeon drilled through the drill guide and placed a 2.9 juggerknot anchor.The surgeon attempted to place a second anchor but it pulled out.The surgeon then tried to seat another anchor but it pulled out as well.On the third attempt the juggerknot anchor held and the surgeon was able to make the soft tissue repair.No additional holes were drilled.During the surgery, the bipolar cup was also removed and replaced by an endo head.

• Brand Name: JGRKNT 2.9MM #2 BLUE MB SNGL
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6963376
• MDR Text Key: 89808082
• Report Number: 0001825034-2017-09216
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 912029
• Device Lot Number: 813260
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR