MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPRESS DEVICE CPS SM SPDL WITH PINS 600LBF; PROTHESIS, KNEE

Catalog Number	178354
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: oss tibial poly bearing 14mm: catalog#150411, lot#65739979; oss poly tibial bushing: catalog#150476, lot#65733841; oss reinforced yoke: catalog#150493, lot#65964072; oss poly bumper lock pin: catalog#150510, lot#65725246; oss 4cm tapered diaph segment: catalog#151837, lot#482670; oss 4cm tapered diaph segment: catalog#151837, lot#66097444; oss rs 7 cm mod seg fmrl-rt: catalog#161011, lot#66163582; oss rs poly fem bushings set/2: catalog#161034, lot#65791052; oss rs poly fem bushings set/2: catalog#161034, lot#66198016; oss rs axle: catalog#161035, lot#66021154; cps anchor plug 10mm: catalog#178400, lot#497100; cps anchor plug 12mm: catalog#178402, lot#497110; cps nut co-cr-mo alloy: catalog#178512, lot#65766783; cps transverse pin 6pk 32mm: catalog#178527, lot#173340; cps centering sleeve 15mm: catalog#178537, lot#65753493; cps/oss 5cm tpr adapt w/oss sc: catalog#178711, lot#65850160.G2: foreign: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an orthopedic salvage procedure.Subsequently, eight (8) months post-implantation, migration was seen in the compress spindle and the patient underwent revision surgery to replace the affected component.It was reported that all available 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.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The event cannot be confirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found 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: COMPRESS DEVICE CPS SM SPDL WITH PINS 600LBF
• Common Device Name: PROTHESIS, KNEE
• 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: 20351604
• Report Number: 0001825034-2024-02312
• Device Sequence Number: 15469457
• Product Code: MBF
• UDI-Device Identifier: 00880304509078
• UDI-Public: (01)00880304509078(17)321107(10)981260
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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 Catalogue Number: 178354
• Device Lot Number: 981260
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male