MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK ZNN NAIL; TRAUMA IMPLANT

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during a clinical study that the patient underwent revision with znn femur nail.No additional patient consequences were reported.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Additional information received clarified that the reported event was not conducted under a clinical study.It was a separate, independent revision.The additional information does not change the results of the previous investigation.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

Additional information received clarified that the reported event was not conducted under a clinical study.It was a separate, independent revision.

Event Description

It was reported approximately four (4) months ago, that the patient underwent a revision surgery of the zmr nail on an unknown date due to migration (nail cut out of bone and into the joint space) along with possible poor bone quality as contributing factor.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The additional information received does not change the root cause of the previous investigation.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: item#: 47248403050; lot#: 64575209, item#: unk; lot#: 2998328, item#: unk; lot#: 2926526.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pertrochantric femur fracture left w/gross dislocation after fall in nursing home.Hx of right hip nailing unknown date.Underwent internal fixation with znn nail.No dob provide, but prior information noted elderly 80-95 yo.Revision was performed on (b)(6) 2020.Indication for removal of nail, there is a cut-out of femoral neck screw.No complications with removal of nail.Cemented hip implant placed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a left hip proximal femoral fracture is present with nail and interlocking screw fixation.The tip of the proximal screw terminates at the superior aspect of the femoral head and there is varus alignment of the fracture.The screw tip does not appear to traverse the articular surface of the femoral head as noted.The bones are osteopenic.The patient's osteopenia could certainly contribute to this finding.Root cause remains the same.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 that patient tripped and fell and sustained left pertrochantric femur fracture.Fracture was repaired with znn nail on approximately one (1) year ago.Subsequently, the nail cut-out of the bone and a revision was performed approximately four (4) days post-implantation.Attempts have been made and no further information has been provided.

• Brand Name: UNK ZNN NAIL
• Type of Device: TRAUMA IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10553211
• MDR Text Key: 207519270
• Report Number: 0001822565-2020-03275
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 90