MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEMENTED FEMORAL COMPONENT; PROSTHESIS KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: ng rot.Hinge knee tib plt sz4 catalog # 00-5880-004-00 lot # 63901409r, art surface 12mm fem sz e catalog # 00-5880-050-12 lot # 64834810, stem implant 12mmdx145mm catalog # 00-5988-010-12 lot # 65479568, stem implant 14mmdx145mm catalog # 00-5988-010-14 lot # 64509180, 15mm tib aug blk sz4 rlat/lmed catalog # 00-5448-004-28 lot # 63923034, 36 deg ele prov liner set 36mm catalog # 00-5490-035-02 lot # 64264990, 5mm distal fem aug sz e catalog # 00-5490-035-10 lot # 64575595.G2 : japan.H3: customer has indicated that the product will not be returned because it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a revision procedure nine months post implantation due to hinge post extension backed out and came off.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.X-ray review indicates a left knee arthroplasty is present with overall anatomic alignment.The hinge post is displaced and separated from the implant with implant displacement anteroinferiorly.Radiolucency is noted along the distal aspect of the femoral implant without evidence of implant loosening.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

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

• Brand Name: CEMENTED FEMORAL COMPONENT
• Type of Device: 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: 17490381
• MDR Text Key: 320699761
• Report Number: 0001822565-2023-02103
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024199149
• UDI-Public: (01)00889024199149(17)251025(10)64731714
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00588001501
• Device Lot Number: 64731714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention