MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2.Report source: india.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a total hip replacement was performed.Subsequently, approximately 3 months post implantation the patient underwent a revision surgery due to unknown reasons.Attempts have been made it and additional information on the reported event is unavailable at this time.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, d10, g3, g6, h2, h3, h6, h11.D10.Unk ml taper stem unk continnum cup unk neutral liner unk bone screw x2 no product was returned; visual and dimensional evaluations could not be performed.Pictures and a video were provided for a different product and not related to the event of revision due to unknown reason.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Medical records were not provided.Due to a lack of available information, a definitive root cause could not be determined.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: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19271471
• Report Number: 0009613350-2024-00163
• Device Sequence Number: 15292520
• Product Code: LZO
• UDI-Device Identifier: 00889024430310
• UDI-Public: (01)00889024430310(17)310131(10)3062236
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 06/20/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00877503201
• Device Lot Number: 3062236
• 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: 04/13/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2021
• 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