MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 HI-WALL E1 LINER 36MM H; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: biolox delta femoral head, catalog#: 650-1057, lot#: 592710; g7 acetabular cup, catalog#: 010000669, lot#: 3350575; taper adapter, catalog#: 650-1068, lot#: 130540; taperloc femoral stem, catalog#: 103207, lot#: 220990; g7 screw, catalog#: 010000999, lot#: 3365486 & 3369626.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event.Please see associated reports: 1825034-2017-01693, 1825034-2017-01695.
Event or Problem Description
It was reported in medical notes received that patient underwent a closed reduction procedure approximately 7 months post-implantation due to dislocation.Subsequently, patient underwent a second closed reduction procedure approximately 12 months post-implantation.Patient underwent a right hip revision procedure approximately 14 months post-implantation due to the reoccurring dislocation.During the procedure, the femoral head and acetabular liner were removed and replaced.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Device was not returned so no product evaluation could be conducted.This device was used for treatment.Device history report was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Third revision reported pre and post diagnosis as failed right total hip arthroplasty.There was no failure of the polyethylene and excellent circumferential ingrowth on the acetabular component.The sciatic nerve that was found to be intact, atraumatic and continuous, the tha had full range of motion and there were no transfusions or complications.There were three event of dislocation; there were no surgeries but recommended therapeutic exercise, gait training, home program instruction.Physical therapy treatment consisted of progressive therapeutic exercises and manual therapy and soft tissue mobilization techniques.Root cause was unable to 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.
Event or Problem Description
No additional information on the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 HI-WALL E1 LINER 36MM H
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6411480
• Report Number: 0001825034-2017-01695
• Device Sequence Number: 16309375
• Product Code: PBI
• UDI-Device Identifier: 00880304527133
• UDI-Public: (01)00880304527133(10)3123575(17)180905
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2022
• 2 Devices were Involved in the Event: 1 2

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: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 010000938
• Device Lot Number: 3123575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: 07/18/2017; 03/14/2022
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 07/21/2017; 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2013
• 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 Age: 59 YR
• Patient Sex: Male