MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL LATERAL FEMORAL PLATE RIGHT 14 HOLES 286 MM LENGTH; PROSTHESIS, TRAUMA

Catalog Number 00235710114

Device Problem Fracture (1260)

Patient Problems Adhesion(s) (1695); Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Non-union Bone Fracture (2369); Osteopenia/ Osteoporosis (2651)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign - event occurred in (b)(6).Other - reported by (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.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 by (b)(6) that a patient was revised approximately two (2) years post-implantation due to implant fracture.Patient was experiencing pain but no other symptoms, and it is unknown what caused the implant to fracture.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 following sections were updated/corrected: a1; a2; a3; a4; b3; b4; b5; b7; d6; e1; e2; e3; g2; g3; g6; h1; h2; h6.The investigation is still in process.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

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: item# 23595055; lot# 63618315.Item# 23594055; lot# 63067675.Item# 23595555; lot# 63108308.Item# 23595555; lot# 63807237.Item# 23595555; lot# 63807237.Item# 484532; lot# 62716313.Item# 484514; lot# 62073572.Item# 23595555; lot# 64071049.Item# 23595555; lot# 64071049.Item# unk screw; lot# unk.Item# unk screw; lot# unk.Visual examination of the returned product identified a zplp bone plate (lot 64302552) was returned.As returned, the plate is fractured.The fracture runs through a threaded hole.Surface damage (nicks & scratches) is seen throughout the entire length of the plate.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: prior to revision during an office visit, it was noted there was no pain, wound healed well.Xray shows healing fracture with no displacement.X-ray report showed osteosynthesis by screwed plate along fracture of the lower extremity of the femur (pt has had a total knee and hip prosthesis).Revision occurred.General anesthesia used.Previous incision utilized, encountered scar tissue.Cancellous bone excised from iliac crest to mix with tbf bank tissue for bone defect in the pseudoarthrosis area.Competitor products placed with stabilization.No complications.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DISTAL LATERAL FEMORAL PLATE RIGHT 14 HOLES 286 MM LENGTH
• Type of Device: PROSTHESIS, TRAUMA
• 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: 12676896
• MDR Text Key: 278116524
• Report Number: 0001822565-2021-03085
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024055964
• UDI-Public: (01)00889024055964(17)290203(10)64302552
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K042598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00235710114
• Device Lot Number: 64302552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 50 KG