MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KINECTIV; PROSTHESIS, HIP

Catalog Number	00771300900
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat: 00784802301, lot: 64746066, modular neck g1, cat: 00877504002, lot: 3084128, bioloxâ® delta, ceramic femoral head, cat: 010000864, lot: 6687390, g7 neutral e1 liner, cat: 110010245, lot: 65459718, g7 osseoti 4 hole shell.G2: foreign ¿ japan.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was not approved for return.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 approximately two years post-implantation, the patient underwent a hip revision due to infection.All components were revised and peeling of the porous coating was noticed on the removed stem.No pieces of the coating remained in the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.H6: proposed code: mechanical (g04) ¿ stem.Visual examination of the provided pictures identified the explanted stem and the delaminated porous coating is seen in several fragments which has delaminated from the stem body.No product was returned; further visual and dimensional evaluations could not be performed.No pictures of the taper were provided.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified devices caused any patient infection.Complaint of coating delaminated can be confirmed, however unable to confirm complaint of infection.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
No further information is available at the time of this report.

• Brand Name: KINECTIV
• Common Device Name: PROSTHESIS, HIP
• 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: 21558447
• Report Number: 0001822565-2025-00554
• Device Sequence Number: 4430382
• Product Code: LPH
• UDI-Device Identifier: 00889024132627
• UDI-Public: (01)00889024132627(17)321113(10)65611929
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/17/2025

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: 00771300900
• Device Lot Number: 65611929
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown