MAUDE Adverse Event Report: BIOMET MICROFIXATION SCRW 2.4X18MM CANCELOUS LOCKNG; PROSTHESIS, MICROFIXATION

Catalog Number 73-2418

Device Problems Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00119.0001032347-2021-00120.0001032347-2021-00121.0001032347-2021-00123.0001032347-2021-00310.0001032347-2021-00311.0001032347-2021-00312.0001032347-2021-00313.0001032347-2021-00314.0001032347-2021-00315.0001032347-2021-00124.0001032347-2021-00316.0001032347-2021-00317.Concomitant medical products: item# 73-2634; lot# unk.Item# unk wire; lot# unk.Item# unk wire; lot# unk.Item# 73-2416; lot# unk.Item# 73-2416; lot# unk.Item# 73-2416; lot# unk.Item# 73-2416; lot# unk.Item# 73-2416; lot# unk.Item# 73-2416; lot# unk.Item# 73-2416; lot# unk.Item# 73-2418; lot# unk.Item# 73-2418; lot# unk.Item# 73-2418; lot# unk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested but not returned by the hospital.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 that the patient was originally implanted approximately three (3) months ago.Subsequently, the patient was revised three (3) days post-implantation due to instability.During the revision, it was found the wires were fractured and the plate was loose.The screws were removed and reused with the new implant.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.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: SCRW 2.4X18MM CANCELOUS LOCKNG
• Type of Device: PROSTHESIS, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11895904
• MDR Text Key: 254480085
• Report Number: 0001032347-2021-00318
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K110574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 73-2418
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2021
• 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: 62 YR