MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK AFFIXUS NAIL; PROSTHESIS, TRAUMA

Catalog Number UNK AFFIXUS NAIL

Device Problem Fracture (1260)

Patient Problems Fall (1848); Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported approximately one (1) year and two (2) months ago, patient was implanted with an unknown affixus nail to repair a trochanter femoris fracture on the right side.Approximately seven (7) months post-op, the patient fell.Xrays were taken approximately two (2) months ago due to patient experiencing pain and had shown the nail had fractured.Patient was revised approximately one (1) week ago to remove the nail.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04368.The lot number originally reported was not the final lot number for the device.The exact final lot number for this product is unknown.The final lot number was identified to be any of the following: lot 743300, lot 709420, lot 709570, lot 752860, lot 745710, lot 743250, lot 743260, lot 743270, lot 709430, lot 709480, lot 709510, lot 709490, lot 709540, lot 709400.Concomitant products: part# 814501095; lot# uk1111295b, part# 814510115; lot# vk1121315a, part# 814550040; lot# unk.The manufacturing dates for all of the final lot numbers listed above are as follows: lot 743300: feb 19, 2019, lot 709420: feb 16, 2019, lot 709570: feb 18, 2019, lot 752860: feb 20, 2019, lot 745710: feb 22, 2019, lot 743250: feb 20, 2019, lot 743260: feb 19, 2019, lot 743270: feb 20, 2019, lot 709430: feb 18, 2019, lot 709480: feb 16, 2019, lot 709510: feb 16, 2019, lot 709490: feb 17, 2019, lot 709540: feb 16, 2019, lot 709400: feb 19, 2019.The investigation is still in progress.Once the investigation is completed, a supplemental report will be submitted.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.

Manufacturer Narrative

Visual inspection of the returned products noted the nail and screw fracture.The returned parts were sent to sem for additional evaluation.For nail - fracture surface revealed artifacts that were consistent with fatigue mode, exhibiting beach marks and fatigue striations.Suspected crack exit area identified near the opposite end of the nail fracture showing the transition from fatigue to overload mode of fracture with ductile dimples.Eds semi-quantitative elemental analysis of the hip fracture nail sample showed that it was consistent with ti-6al-4v alloy.Medical records were not provided.X-rays provided were sent to an external hcp for review.Their review noted the following: implant fit and alignment appear maintained although as noted one of the femoral neck surgical screws is fractured.Bone quality is osteopenic.Device history record was not reviewed as the material analysis noted the implant material is conforming to specifications.It was mentioned that the patient fell in (b)(6)2020, which could potentially lead to the fracture of the implants.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: UNK AFFIXUS NAIL
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10641612
• MDR Text Key: 210365130
• Report Number: 0001825034-2020-03729
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AFFIXUS NAIL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR