MAUDE Adverse Event Report: BIOMET MICROFIXATION 50MM LFT NARROW MAND; PROSTHESIS, MICROFIXATION

Catalog Number	01-6551
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00351.Concomitant medical products: item# 24-6563; lot# 027870a.Item# 24-6555; lot# 753700a.Item# 24-6562; lot# 988720d.Item# 24-6551; lot# 017810c.Item# 24-6565; lot# 816590c.Full establishment name - (b)(6) medical center.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.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 or Problem Description
It was reported that a patient underwent an initial segment procedure approximately two (2) months ago.Subsequently, the patient was revised on the left side approximately one (1) month post-implantation.Surgeon was not happy with the placement of the implant and replaced the fossa with a larger model.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to a user error in the placement of the implant.It was reported that the patient was revised because the surgeon was not happy with the placement of the implant.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: 50MM LFT NARROW MAND
• Common Device Name: PROSTHESIS, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12018466
• Report Number: 0001032347-2021-00350
• Device Sequence Number: 1374837
• Product Code: LZD
• UDI-Device Identifier: 00841036060428
• UDI-Public: (01)00841036060428
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2023
• Device Catalogue Number: 01-6551
• Device Lot Number: 863330B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female