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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 12/19/2022

Event Type  Injury  

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 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.

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 Description

It was reported that the patient underwent revision surgery due to wound complication, hematoma and draining sinus.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 32/-3.5, TAPER 12/14
• Type of Device: 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
• MDR Text Key: 308914705
• Report Number: 0009613350-2023-00040
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430310
• UDI-Public: (01)00889024430310(17)310504(10)3069804
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 91 KG