MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HEADS; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Medical device site infection (4845)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D6a: device was implanted on an unknown date in (b)(6) 2024.D10: unknown avenir stem, unknown item and lot #.Unknown allofit-it cup 54, unknown item and lot #.Unknown pe liner, unknown item and lot #.G2: foreign: belgium.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.
Event or Problem Description
It was reported that a patient had second stage revision surgery due to periprosthetic joint infection and abscessation, approximately 6 months after implantation.In first stage the patient had revision hip prosthesis for removal and spacer insertion, approximately 1 month later the patient had the second stage for new devices implantation.Due diligence has been completed for this complaint; to date all available additional information has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; d10; g3; h2; h3: h6; h11 d10: allofit-it cup 54 unknown item #00875505400 and lot# 3179814 femoral stem cementless collarless coxa vara 12/14 taper size 6 item# 574103060 and lot#3080152 36mm i.D.Size jj neutral liner use with 54mm o.D.Size jj shell item# 00875101136 and lot#65918642.
Event or Problem Description
No additional event information at this time.
Additional Manufacturer Narrative
During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: BIOLOX DELTA HEADS
• 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: 20145924
• Report Number: 0009613350-2024-00430
• Device Sequence Number: 4248414
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)330530(10)3143611
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877503602
• Device Lot Number: 3143611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 10/31/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/16/2024; 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2023
• 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.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White