MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Unspecified Infection (1930)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was evaluated in the er for pulmonary embolism receiving iv dye leading to anaphylactic shock and respiratory failure about two months after initial left total hip arthroplasty.During hospitalization patient was also diagnosed with an unknown infection.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: g7 osseoti multihole 50mm d, item#: 110010263, lot#: 65273694; bone scr 6.5x30 self-tap, item#: 00625006530, lot#: j7370441; bone scr 6.5x25 self-tap, item#: 00625006525, lot#: j7348344; g7 longevity high wall 32mm d, item#: 20123204, lot#: 64580191; femoral stem press-fit collarless 12/14 neck taper standard body extended neck offset size 13 138mm stem length cementless, item#: 00786401320, lot#: 65603489.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
The patient underwent an initial left total hip arthroplasty.Fourteen (14) days later, the patient had excessive drainage and hematoma requiring joint debridement.Approximately, one month later, the patient was evaluated in the er for pulmonary embolism receiving iv dye leading to anaphylactic shock and respiratory failure.The patient was initially treated with rocephin.However, it was noted that the patient did not have an anaphylactic shock to rocephin but to contrast dye resulting in respiratory failure, requiring intubation and admission to icu.The patient was sedated and intubated in icu.During hospitalization, it was reported that the patient was diagnosed with an unknown infection and discharged home.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 16321130
• Report Number: 0009613350-2023-00044
• Device Sequence Number: 20807110
• Product Code: LZO
• UDI-Device Identifier: 00889024430327
• UDI-Public: (01)00889024430327(17)320427(10)3112555
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-032-02
• Device Lot Number: 3112555
• 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: 02/14/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Race: White