MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 45MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: ref 00700006220 lot 63959491 tm shell; ref 00710506240 lot 64210793 longevity liner; ref 00625006520 lot 63010444 screw; ref 00625006530 lot j6858532 screw; ref 00625006540 lot 64825901 screw; ref 00625006540 lot j6710215 screw; ref 650-1058 lot 3043515 biolox head; ref 650-1066 lot 3050922 biolox sleeve; ref 00710506240 lot 64210793 longevity liner; ref 51-104150 lot 6948764 taperloc stem; ref 00223200418 lot 64952399 cerclage wire.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02934.
Event or Problem Description
It was reported the patient underwent left tha due to femoral neck fracture.Subsequently, patient was revised two days later due to an iatrogenic acetabular fracture.The patient underwent a second revision approximately 4 months later due to pain and instability with placement of a custom cage and constrained liner.During the revision, significant scarring was noted which prompted the removal of the femoral component.The acetabular component was found well fixed and ingrown.The cemented liner was removed as well as the cup.Backing out the screws was not possible, so the surgeon cut them with a bur so that the custom cage could be placed.Due to intraoperative complications, only the custom cage, liner, and screws were placed.The wound was closed without femoral components in place, and the patient was transferred to the critical care unit.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
Upon reassessment of the reported event, the screw was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Upon reassessment of the reported event, the screw was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: G7 SCREW 6.5MM X 45MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12688893
• Report Number: 0001825034-2021-02935
• Device Sequence Number: 1480097
• Product Code: LPH
• UDI-Device Identifier: 00880304527508
• UDI-Public: (01)00880304527508(17)270112(10)3957282
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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: 010001002
• Device Lot Number: 3957282
• 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: 10/01/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2017
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 63 KG