MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR SCREW 6.5MM X 35MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unequal Limb Length (4534)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b(4).G2: foreign ¿ australia.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 two years post-implantation the patient was revised due to a fractured acetabulum.The surgeon stated that acetabulum fracture cause is unknown but may have occurred at the time of implantation and went unnoticed.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: g3; h2; h3; h5; h6; h10.The following sections were corrected: d5.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.Radiographs were provided and review identified the following: medial wall acetabular fracture with medial migration of the loose acetabular cup as noted.Fracture of at least one of the acetabular fixation screws a definitive root cause cannot be determined.This complaint was confirmed based on the x-ray review confirming the reported event.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 35MM
• 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: 19331282
• Report Number: 0001825034-2024-01255
• Device Sequence Number: 7009736
• Product Code: PBI
• UDI-Device Identifier: 00880304527485
• UDI-Public: (01)00880304527485(17)311018(10)7124153
• 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: 2022
• 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): 08/23/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010001000
• Device Lot Number: 7124153
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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: Female
• Patient Weight: 52 KG