MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7; PROSTHESIS, HIP

Catalog Number	010000665
Medical Device Problem Codes	Material Erosion (1214); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Necrosis (1971); Pain (1994); Subluxation (4525); Metal Related Pathology (4530); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation, as its 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
It was reported that approximately three years post-implantation, the patient underwent a left hip revision due to unknown reasons.Attempts have been made and no further information has been provided.
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: d4; g3; h2 the following sections were corrected: d1; d2 product code the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a4-6; b1; b5-7; d4 lot; d10; g3; h6.The following sections were corrected: d4 cat#; d6; e1.D6b: device was retained and not explanted.D10: cat# 650-0662 lot# 3043983 delta ceramic fem hd 36/+3mm.Cat# 20153606 lot# 64849786 36mm i.D.Size f +5mm offset liner.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 two years post-implantation, the patient underwent a right hip revision due pain, squeaking, swelling, and redness in the hip.The patient felt a pop like when moving a box at work, but x-rays did not see any findings.It felt like something rolled in the anterior aspect of the hip and rolled back.There was progressive pain and approximately three weeks later, x-ray showed the head articulating against the cup with the poly liner disassociated from the cup.There were elevated crp levels, which indicated inflammation and infection risk so the patient underwent an irrigation and debridement with head and liner exchange.During the procedure, there was significant metallosis identified through the hip and tears in the fascia.Necrotic tissue and pieces of the loose, fractured poly liner were removed.The hip was thoroughly irrigated and there was ebl of 850ml with prbcs transfused.The stem and shell remained.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: d4; g3; g4; h2; h3; h4; h6; h10.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 right tha was performed.While at work moving a box, the patient felt a pop in his hip.X-rays did not show any acute findings after the event.Additional x-rays taken later on showed the head was articulating against the cup and the poly had disassociated.A revision occurred, where disassociation and fracture of the liner was confirmed, as well as subsidence of the right hip.There was also metallosis/pseudocapsule throughout the joint.The metallosis was noted throughout the head, but the trunnion of the stem appeared okay.A tear was also noted in the fascia.The head and liner were explanted and replaced.The stem and cup remained implanted.A definitive root cause cannot be determined.Complaint is 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b7; g3; h2.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.

• Brand Name: G7
• 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: 22805021
• Report Number: 0001825034-2025-02464
• Device Sequence Number: 15367895
• Product Code: PBI
• UDI-Device Identifier: 00880304524248
• UDI-Public: (01)00880304524248(17)301203(10)6911117
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/13/2025

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: Lay User/Patient
• Device Catalogue Number: 010000665
• Device Lot Number: 6911117
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 09/30/2025; 10/30/2025; 11/25/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/24/2025; 10/09/2025; 11/19/2025; 12/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• 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 Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White