MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL ARCOMXL LNR 36MM G; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Pain (1994); Joint Dislocation (2374)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 12-115122 lot# 2971570 cer bioloxd mod hd 36mm +3 nk.Product was returned and evaluated.A visual examination of the returned product identified that the returned head had worn down.The liner showed indentations and gouging to the outer diameter and lip.The inner radii show some black scuff marks along with scuffing to the surface of the device.The reported issue was confirmed based on evaluation of the returned products.Radiographs were also provided and reviewed by a health care professional.A review of the available records identified the following: implant fit is maintained.There is lateral polyethylene liner wear with eccentric femoral head position as noted.No loosening or abnormal radiolucency is noted.A review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.A definitive root cause cannot be determined.However, it was noted that the patient experienced a fall.It is unknown if the fall caused or contributed to 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.
Event or Problem Description
It was reported that approximately 4 years post implantation of left hip arthroplasty, the patient experienced a work related fall and suffered a clavicle fracture as a result of the fall.After the fall, the patient began experiencing squeaking during ambulation, along with slight discomfort.The patient was subsequently revised.During the revision, it was noted that the femoral head was wearing against the shell.The head and liner were exchanged, with the surgeon exchanging the liner from a size 36 to 40.Though requested, no additional information has been provided.

• Brand Name: G7 NEUTRAL ARCOMXL LNR 36MM G
• Common Device Name: PROTHESIS, 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: 17040361
• Report Number: 0001825034-2023-01146
• Device Sequence Number: 6908610
• Product Code: PBI
• UDI-Device Identifier: 00880304524996
• UDI-Public: (01)00880304524996(17)220821(10)6109134
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2023

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: 08/21/2021
• Device Model Number: N/A
• Device Catalogue Number: 010000742
• Device Lot Number: 6109134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• 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: 05/16/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male