MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 32/-3.5, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	00-8775-032-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Hematoma (1884); Unspecified Infection (1930); Post Operative Wound Infection (2446)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products.Item#:00625006530 ;lot#:j7352161 ;item name: bone screw self-tapping 6.5 mm dia.30 mm length ; item#:00625006530 ;lot#:j7352156 ;item name: bone screw self-tapping 6.5 mm dia.30 mm length; item#:00786401320 ;lot#:65603489 ;item name: femoral stem press-fit collarless 12/14 neck taper standard body extended neck offset size 13 138 mm stem length cementless; item#:110010263 ;lot#:65506475 ;item name: g7 osseoti multihole 50mm d; item#:20123204 ;lot#:65462155 ;item name: 32mm i.D.Size d high wall liner.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent additional medical intervention due to wound complication, hematoma and draining sinus.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Review of the medical records by a hcp identified initial left total hip arthroplasty performed in 2022.Subsequently, the patient developed a postop hematoma with wound drainage.Patient was placed on prophylactic oral antibiotics.In 2022, the patient underwent an irrigation and debridement of the wound with no product exchange.The surgeon noted no evidence of deep infection, the hematoma was evacuated, and the wound closed after irrigation.Intra op cultures were negative but patient was placed on iv antibiotic therapy.The patient continued to experience wound drainage and presented to the emergency department with signs of infection at the hip while also covid positive.The patient underwent a second irrigation and debridement but with head and liner exchange in 2023.From that procedure, cultures were positive for pseudomonas a growth.The patient will continue iv antibiotics and follow up with an infectious disease specialist.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, therefore implanted products are not identified as the source or contributing to the reported 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
It was reported that the patient underwent revision surgery due to wound complication, hematoma and draining sinus.
Event or Problem Description
It was reported that a patient had an initial left total hip arthroplasty.Subsequently, the patient developed a postop hematoma with wound drainage.Patient was placed on prophylactic oral antibiotics.Approximately one month post implantation, the patient underwent an irrigation and debridement of the wound with no product exchange.The surgeon noted no evidence of deep infection, the hematoma was evacuated, and the wound closed after irrigation.Intraop cultures were negative, but patient was placed on iv antibiotic therapy.The patient continued to experience wound drainage and presented to the emergency department with signs of infection at the hip while also covid positive.Then, the patient underwent a second irrigation and debridement but with head and liner exchange.From that procedure, cultures were positive for pseudomonas a growth.The patient will continue iv antibiotics and follow up with an infectious disease specialist.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: b4, b5, b7, e1, g3, g6, h2, h6, h11.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, 32/-3.5, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER 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: 16310546
• Report Number: 0009613350-2023-00040
• Device Sequence Number: 6803502
• Product Code: LZO
• UDI-Device Identifier: 00889024430310
• UDI-Public: (01)00889024430310(17)310504(10)3069804
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2024

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: 00-8775-032-01
• Device Catalogue Number: 00-8775-032-01
• Device Lot Number: 3069804
• 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: 01/11/2023
• Supplement Date Received by Manufacturer: 02/10/2023; 11/11/2024
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/08/2023; 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 91 KG