MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR SYSTEM DUAL MOBILITY LINER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6 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.Medical records were not provided.The root cause of the reported issue is attributed to user error.The liner is not intended to be cemented.Additionally, the combination of the cup and the cage are not compatible.Per the ifu, the liners are single use implants, intended for uncemented applications.Per the ifu, the cage is designed to be layered between a revision shell and a polyethylene liner using cement fixation.Improper selection, placement, and positioning of the implant components may result in unusual stress conditions and subsequent reduction in the service life of prosthetic implants.This complaint cannot be confirmed.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 or Problem Description
No further information is available at the time of this report.
Event or Problem Description
It was reported patient has been indicated for revision due to unknown reasons.No revision has been reported to date.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately six months post-implantation, the patient is being considered for a revision with a triflange implant due to failure of the cemented liner within the cup/cage construct.A revision has not been scheduled to date.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a2; a3; b7; d6a; d10; g3; g4; h2; h4.The following sections were corrected: b1; b5; d1; d2; d4; h6 clinical code and device code d10: cat# 00712505648 lot# 3106018 acetabular revision system - cage, right long flange use with 56/58/60 mm shells.Cat# 110010266 lot# 66210108 g7 osseoti multihole 56mm f unk cement.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: G7 ACETABULAR SYSTEM DUAL MOBILITY LINER
• 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: 19575435
• Report Number: 0001825034-2024-01651
• Device Sequence Number: 17129565
• Product Code: LPH
• UDI-Device Identifier: 00880304703490
• UDI-Public: (01)00880304703490(17)330929(10)66298142
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K150522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2024
• 2 Devices were Involved in the Event: 1 2

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 Model Number: N/A
• Device Catalogue Number: 110024461
• Device Lot Number: 66298142
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 06/19/2024; 10/29/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/11/2024; 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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: Other
• Patient Sex: Female