MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN POSTERIOR FEMORAL AUGMENT BLOCK PRECOAT SIZE F 5MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Ambulation or Postural Difficulties (2544)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - nexgen cemented option femoral component left size f catalog #: 00599401691 lot #: 63376531, nexgen straight stem extension 17mm x 100mm catalog #: 00598801017 lot #: 62319367n, nexgen distal femoral augment block precoat size f 10mm catalog #: 00599003620 lot #: 62917296, nexgen posterior femoral augment block precoat size f 5mm catalog #: 00599003601 lot #: 63088982, nexgen distal femoral augment block precoat size f 10mm catalog #: 00599003620 lot #: 62917296, nexgen articular surface with locking screw green 10mm size e, f catalog #: 00599404010 lot #: 62227678, nexgen stemmed precoat tibial component size 6 catalog #: 00598004702 lot #: 63377478, nexgen tibial block and screws size 6 5mm catalog #: 00598800626 lot #: 63101473, nexgen straight stem extension 12.7mm x 30mm catalog #: 00598801212 lot #: 62719567, nexgen tibial block and screws size 6 5mm catalog #: 00598800626 lot #: 63108231, nexgen standard all poly patella size 35mm catalog #: 00597206535 lot #: 61113009.The complainant has indicated that 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.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision of the femoral and articular surface components to address pain, instability, scar tissue and femoral implant loosening approximately three (3) years following the patient's last knee arthroplasty.Initial operative notes noted no intraoperative complications.Revision operative notes note the patient was undergoing a left knee revision with extensive synovectomy and release of scar tissue as well as application of long leg splint under anesthesia.The femoral components and polyethylene were exchanged without complications.
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.Medical records provided confirmed the patient's reported instability and pain.Radiographic review of x-rays provided identified anatomic alignment and progressive osteopenia with no signs of loosening, wear, radiolucency or abnormalities.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.

• Brand Name: NEXGEN POSTERIOR FEMORAL AUGMENT BLOCK PRECOAT SIZE F 5MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20146496
• Report Number: 0001822565-2024-02861
• Device Sequence Number: 18217984
• Product Code: JWH
• UDI-Device Identifier: 00889024224162
• UDI-Public: (01)00889024224162(17)250731(10)63088982
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K960279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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 Expiration Date: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00599003601
• Device Lot Number: 63088982
• 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: 08/17/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2015
• 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
• Patient Weight: 86 KG