MAUDE Adverse Event Report: BIOMET TRAUMA TSP HIP FX PLATING NECK FRACTURE PLATE; DEVICE, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2017-02254, 0001825034-2017-02255 and 0001825034-2017-02256.Concomitant medical products: tsp hip fx plating 7.5mm telescoping lag screw, catalog #: 14-451085, lot #: 815460; tsp hip fx plating 7.5mm telescoping lag screw, catalog #: 14-451095, lot #: 193960; tsp hip fx plating 7.5mm telescoping lag screw, catalog #: 14-451080, lot #: 933380.Customer has indicated that the product will not be returned to zimmer biomet for evaluation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the patient underwent a hip fracture trauma plating procedure and began experiencing low back pain and iliotibial band tightness onset approximately three (3) months post-operatively.Subsequently, one year post-operative follow-up noted the patient has some difficulty laying on operative side, thigh pain, leg pain, and back pain.However, the device was noted to be performing well with no issues noted.The patient was hospitalized and received medication to treat the back pain.The surgeon stated that the leg pain could be related to the back pain.No additional patient consequences were reported.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.Reported event was confirmed by review of x-rays and medical records.Post op x-rays show that the hardware is intact and stable.During the patients 3 month post op appointment, the patient complained of low back pain and it band tightness.X-ray were taken and the hardware is intact, stable, and maintaining good alignment.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.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: TSP HIP FX PLATING NECK FRACTURE PLATE
• Type of Device: DEVICE, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 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: 6483356
• MDR Text Key: 72497423
• Report Number: 0001825034-2017-02257
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

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 Model Number: N/A
• Device Catalogue Number: 14-451002
• Device Lot Number: 739700
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/11/2017
• Supplement Dates Manufacturer Received: 01/12/2018
• Supplement Dates FDA Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2014
• 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: 69 YR
• Patient Weight: 67