MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 4 HOLE SHELL 58MM G; PROSTHESIS, HIP

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	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent initial left total hip arthroplasty.Subsequently, patient had a possible i & d approximately 1 month later.The patient was revised approximately 2 months post implantation due to deep infection.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
D10: explanted product stage 1: acetabular cup ¿ 110010247, lot 6815876 acetabular liner ¿ 30123607, lot 64802478 femoral head component ¿ 6500661, lot 3030565 femoral stem ¿ 51103160, lot 6454785 explanted product stage 2: djo bone cement ref 600-15-000 lot 939d1d0042 g7 liner ref 30123607 lot 64926920 depuy head and spacer.
Event or Problem Description
It was reported that the patient underwent initial left total hip arthroplasty.Subsequently, the patient underwent stage 1 revision due to infection approximately 1 month later.Stage 2 reimplantation occurred approximately 3 months later.No further event information available at the time of this report.
Additional Manufacturer Narrative
Upon reassessment of the reported event, the device was determined to be not reportable.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.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon reassessment of the reported event, the device was determined to be not reportable.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.The initial report was forwarded in error and should be voided.

• Brand Name: G7 OSSEOTI 4 HOLE SHELL 58MM G
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11382110
• Report Number: 0001825034-2021-00585
• Device Sequence Number: 14388298
• Product Code: PBI
• UDI-Device Identifier: 00887868355912
• UDI-Public: 00887868355912
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010247
• Device Lot Number: 6815876
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/31/2021; 05/14/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/20/2021; 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: ZIMMER HEAD CAT#6500661 LOT#3030565; ZIMMER LINER CAT#30123607 LOT#64802478; ZIMMER HEAD CAT#6500661 LOT#3030565; ZIMMER LINER CAT#30123607 LOT#64802478
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 109