MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR SCREW 6.5MM X 15MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately three days post-implantation, the patient underwent a left hip revision due to cup loosening.The cup, screws, liner, bearing, and head were revised.The stem was retained.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat #: ep-200160, lot #: 507990 , act artic e1 hip brg 28x54mm.Cat #: 110024467, lot #: 695130, g7 dual mobility liner 54mm i.Cat #: 650-1055, lot #: 3166135, cer bioloxd option hd 28mm.Cat #: 650-1064, lot #: 3162350, cer option type 1 tpr sleve -6.G2: foreign ¿ australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as is location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further information is available at the time of this report.
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; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and review of the available records identified the following: fracture of posterior and superior wall with cup loosening.Radiographs identified the following: loose acetabular cup with displacement and vertical cup orientation.A pelvic fracture is not identified in the x-ray views, but cannot be excluded given the cup displacement.A definitive root cause cannot be determined.The patient had previous trauma requiring pelvic surgery.It is unknown if this past history contributed to the reported event.The complaint is confirmed due to the x-ray findings and medical record review.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: G7 ACETABULAR SCREW 6.5MM X 15MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19386902
• Report Number: 0001825034-2024-01351
• Device Sequence Number: 17161582
• Product Code: PBI
• UDI-Device Identifier: 00880304527447
• UDI-Public: (01)00880304527447(17)330119(10)7426709
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/24/2024

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 Model Number: N/A
• Device Catalogue Number: 010000996
• Device Lot Number: 7426709
• 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: 05/03/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 85 KG