MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HDLS CMPN SCR 2.5X16 NS; TRAUMA, IMPLANT

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Joint Laxity (4526)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 110018418; lot# unk; hdls cmpn scr 2.5x16 ns.Foreign: event occurred in (b)(6).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00819.Remains implanted.

Event Description

It was reported that the patient underwent an initial surgery.Subsequently, the patient was experiencing low foot function and stiffness.Two headless compression screws were implanted in the hallux of the left foot.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial surgery for left foot bunionectomy, osteotomy, and plantar plate repair.Subsequently, the patient reported pain and stiffness leading to an additional surgery.A scar tissue and tendon transfer was performed with implantation of competitor screws.No zimmerbiomet product was removed.The patient did well for 6 months post-op then began experiencing stiffness again in the mtp2.

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.Reported event was confirmed by review of medical records noting patient experienced continued pain after about a year post implantation.Tendinosis and tenosynovitis, recurring of hallux valgus due to metatarsal laxity and a posterior tear with arthrofibrosis mtp2 left foot.Debridement of the necrotic tendon tissue anchoring of tibial tendon, ligaments intact.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause is unable to 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.

• Brand Name: HDLS CMPN SCR 2.5X16 NS
• Type of Device: TRAUMA, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11613359
• MDR Text Key: 246601488
• Report Number: 0001825034-2021-00818
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K142658
• 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: 06/16/2021

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 Model Number: N/A
• Device Catalogue Number: 110018418
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 04/01/2021; 06/10/2021
• Supplement Dates FDA Received: 04/26/2021; 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 49 YR
• Patient Weight: 79