MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEGMENT WITH MALE/FEMALE TAPER 30 MM LENGTH; PROSTHESIS, KNEE

Catalog Number	00585004603
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient has experienced intense pain in the left thigh since initial stages of previous surgeries.The patient was revised approximately 4 years post implantation due to loosening.It was noted the explanted prosthetic components showed no signs of real damage, breakage, wear or other mechanical problems, except for the absence of osteointegration of the femoral stem.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in italy.H6: component code: mechanical (g04) - stem.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h11.No products were returned.Photographs of the reported device were provided however the reported loosening could not be confirmed from the images.The device history record was reviewed and no discrepancies relevant to the reported event were found.X-rays were reviewed but did not contribute any findings relevant to the investigation.A definitive root cause cannot be determined.The reported event cannot be confirmed.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: SEGMENT WITH MALE/FEMALE TAPER 30 MM LENGTH
• 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: 22063075
• Report Number: 0001822565-2025-01505
• Device Sequence Number: 7849982
• Product Code: KRO
• UDI-Device Identifier: 00889024195998
• UDI-Public: (01)00889024195998(17)320430(10)65375359
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K070978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• 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): 10/13/2025

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: Lay User/Patient
• Device Catalogue Number: 00585004603
• Device Lot Number: 65375359
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Unknown