MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 70MM I; PROSTHESIS, HIP

Catalog Number	110010273
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00007, 0001822565-2023-00009, 0001822565-2023-00010, 0001822565-2023-00011, 0001822565-2023-00012.Concomitant medical products:¿ 00625006525/j7109046/ bone scr 6.5x25 self-tap, 00625006550/j6965914/ bone scr 6.5x50 self-tap, 00625006525/j7126860/ bone scr 6.5x25 self-tap, 00625006540/j7119546/ bone scr 6.5x40 self-tap, 00625006520/64735195/ bone scr 6.5x20 self-tap, 010000987/6747591/ g7 freedom const e1 lnr 36mm i, 11-107020/585670/freedom contsr hd 36mm t1 + 6mm.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent a right hip revision approximately one-year post implantation due to loosening and an infection.During the procedure it was noted that some of the screws were broken, some of them pulled through the cup and others had pulled out of the cup.The cup and screws were removed and replaced.Attempts have been made and no further information is available.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; g3; h2; h3; h6 corrected: b2 b2: 'other' was selected in error during the initial report.'required intervention.' is the appropriate option for this event and has been selected now.Visual examination of the provided picture identified the explanted shell and some screws covered in bio-debris.Some of the screws are shown sticking out of the shell holes.One of the screws appears fractured.No further evaluation can be made from the provided pictures.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined for the loosening and screws breaking/pulling out of the cup.No problem was found with the implants in relation to the infection.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 OSSEOTI MULTIHOLE 70MM I
• 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: 16382765
• Report Number: 0001825034-2023-00173
• Device Sequence Number: 20292307
• Product Code: LPH
• UDI-Device Identifier: 00880304544482
• UDI-Public: (01)00880304544482(17)281030(10)6416662
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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 Catalogue Number: 110010273
• Device Lot Number: 6416662
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2018
• 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 H10
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 127 KG