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); Pain (1994); Non-union Bone Fracture (2369); No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (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

This follow-up report is being submitted to relay additional information.The following sections were corrected: b5; g3 the following sections were updated: b4; g4; g7; h1; h2 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

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.The following sections were updated: b4, b5, e1, e2, e3, g4, g7, h1, h2, h6, h10 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 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.

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.

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.

Event Description

It was reported that the patient tripped and fell and sustained left pertrochantric femur fracture.Fracture was repaired with znn nail approximately nine (9) months ago.Subsequently increasing pain was reported due to increasing cut-out of nail and revision was performed approximately two (2) post-implantation.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: item# 40248404050; lot# 64317656; item# unk; lot# 2998798; item# unk; lot# 2998328.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial images show good stability & full weight bear was allowed.Notes there was an increasing cut-out of the nail, so that the indication for a change procedure had to be made due to increasing pain.No other non-operative alternatives.Removed distal locking bolt, removal of proximal cap, was unable to remove during first attempt due to small incision and increased incisional site, this allowed bolt and nail to be easily removed without difficulties.Upon view of pertrochanteric femur fracture was non-healed.Found fragments attached at muscle, resection of femoral neck and head.Notes decubitus grade 3 right heel, 1st postoperative day (b)(6) 2020.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the left hip demonstrate left femoral intramedullary rod with single distal interlocking screw.Gamma nail seen proximally for what appears to be a intertrochanteric fracture.Second ap film demonstrates lucency surrounding the gamma nail with apparent subsidence and incomplete healing of the femoral intertrochanteric fracture.Overall fit of the implants is appropriate.Suggestion of subsidence and loosening on the second ap film.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.

• 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: 10553207
• MDR Text Key: 207519712
• Report Number: 0001822565-2020-03276
• 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: 04/28/2021

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 12/03/2020; 12/29/2020; 01/12/2021; 04/26/2021
• Supplement Dates FDA Received: 12/17/2020; 12/29/2020; 01/22/2021; 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 95