MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM ACETABULAR SYSTEM TRABECULAR METAL SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately two year post-implantation, the patient was revised following reported pain and the cup was suspected of being loose.An infection was confirmed upon intra-operative biopsy.It is unknown which components were revised.An antibiotic spacer was placed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 00875101036 lot# 63123933 36mm i.D.Size ii neutral liner cat# 00801803602 lot# 63177076 femoral head 12/14 taper cat# 00771100720 lot# 11013862 femoral stem size 7.5 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided.Review identified the following: an initial left tha was performed with no complications noted.The patient reported pain nineteen months later and the cup was suspected to be loose.An intra-op biopsy confirmed infection.An antibiotic spacer was placed.It is unknown what implants were revised for the spacer.A definitive root cause cannot be determined for the cup loosening.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.This complaint was confirmed based on the provided medical records.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: CONTINUUM ACETABULAR SYSTEM TRABECULAR METAL SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19340552
• Report Number: 0001822565-2024-01635
• Device Sequence Number: 8966367
• Product Code: JDI
• UDI-Device Identifier: 00889024151376
• UDI-Public: (01)00889024151376(17)250930(10)63187650
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 00875705201
• Device Lot Number: 63187650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2015
• 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 H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Race: White