MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CER OPTION TYPE 1 TPR SLEVE -6; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign australia.Concomitant medical products: 650-1064, ceramic taper, 3064989.650-1055, ceramic head, 2020011173.110010267, g7 osseoti multihole 58mm g, 7196541.Ep-200152, act artic e1 hip brg 28x46mm, 930800.110024465, g7 dual mobility liner 46mm g, 106480.010000997, g7 screw 6.5mm x 20mm, 7165751.010001001, g7 screw 6.5mm x 40mm, 6984426.010000999, g7 screw 6.5mm x 30mm, 7289383.11-301305, arcos con sz e std 60mm, 037720.Unk arcos stem, unk arcos stem, unknown.47249009700, tear drop guide wire, 65316177.166069, arcos screw, 6828663.166069, arcos screw, 7032015.166070, arcos screw, 6970413.166068, arcos screw, 7053131.166067, arcos screw, 7197916.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00018.Product will not be returned to zimmer biomet for the investigation as the product was discarded.The investigation is in process.Once the investigation as been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a initial left hip revision arthroplasty.Approximately, one month later the patient underwent a 1st stage revision due bacterial infection.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
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, 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE -6
• 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 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: 16202066
• Report Number: 0009613350-2023-00017
• Device Sequence Number: 12126061
• Product Code: LZO
• UDI-Device Identifier: 00887868271465
• UDI-Public: (01)00887868271465(17)310430(10)3064989
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192683
• 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): 03/13/2023

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: 650-1064
• Device Lot Number: 3064989
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 185 KG