MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM MOD ARTHRO 0 DEG LCK COLLAR; Rod, Fixation, Intramedullary And Accessories

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a left knee revision approximately two years post-implantation due to instability.
Additional Manufacturer Narrative
(b)(4).D10 medical devices: cps lg spdl with pins 600lbf, catalog #: 178357, lot #: 030780.Oss por straight stem 14.5x150, catalog #: 150450, lot #: 463180.Mod arthro nl 3cm diasl cnctr, catalog #: cp260607, lot #: 643710.Mod arthro nl 3cm elip cnctr, catalog #: cp260608, lot #: 360440.Cps nut co-cr-mo alloy, catalog #: 178512, lot #: 954300.Cps transverse pin 6pk 36mm, catalog #: 178528, lot #: 097450.Cps anchor plug 20mm, catalog #: 178410, lot #: 752800.G2 foreign source: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Visual evaluation of a picture provided identified an explanted collar with foreign material on it.Radiographic review did not identify any hardware failure.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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.
Event or Problem Description
It was reported that patient underwent a left knee arthroplasty revision approximately two (2) years post-operatively to address instability from screw loosening.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1, b4, b5, g3, g6, h2, h6, h11.

• Brand Name: ORTHOPEDIC SALVAGE SYSTEM MOD ARTHRO 0 DEG LCK COLLAR
• Common Device Name: Rod, Fixation, Intramedullary And Accessories
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19518876
• Report Number: 0001825034-2024-01558
• Device Sequence Number: 12269761
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2026

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 Model Number: N/A
• Device Catalogue Number: CP260600
• Device Lot Number: 893750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 08/21/2026
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 11/12/2024; 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male