MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 50MM H; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Scar Tissue (2060)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent an endoscopic procedure approximately eleven(11) years post implantation to remove scar tissue, release right hip flexor tendon & remove bursa.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item number 0100102219 item name wagner sl revision stem19/225 lot # 2947807.Item number 00801802801 item name femoral head sterileproduct do not resterilize 12/14 taper lot # 62523867.Item number 00625006520 item name bone scr 6.5x20 self-tap lot # 64106455.Item number 00625006530 item name bone scr 6.5x30 self-tap lot # 63948639.Item number 00625006535 item name bone scr 6.5x35 self-tap lot # 63897395.Item number 00625006540 item name bone scr 6.5x40 self-tap lot # 64172354.Review of the device history records identified no deviations or anomalies during manufacturing no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent an endoscopic procedure to remove scar tissue and release right hip flexor tendon & remove bursa.Recurrent flexor tendonitis, iliopsoas bursitis, endoscopic hip flexor tendon release, right bursectomy.Pain, received 3 injections prior to procedure with only temporary relief.Right hip endoscopic procedure to release hip flexor tendon and remove bursa.Scar tissue debrided a definitive root cause could not be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -02261.0001825034 -2021 -03113.

• Brand Name: G7 DUAL MOBILITY LINER 50MM H
• 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: 12797761
• Report Number: 0001825034-2021-03112
• Device Sequence Number: 14864050
• Product Code: LPH
• UDI-Device Identifier: 00880304703544
• UDI-Public: (01)00880304703544(17)281011(10)411470
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 11/11/2021

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: 110024466
• Device Lot Number: 411470
• 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: 11/10/2021
• Initial Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2018
• 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
• 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: Unknown
• Patient Weight: 93 KG