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	02/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item#010000669, g7 shell, lot#3350575; item #010000999, g7 screw, lot #3365486, item #010000999, g7 shell, lot#3369626; item #103207, taperloc femoral stem, lot#220990.Multiple mdr reports were filed for this event, please see associated report: 0001825034 - 2017 - 01692.
Event or Problem Description
It was reported in medical notes received that patient experienced dislocation approximately 5 months post-implantation.It is unknown if medical intervention took place.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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.The following sections were updated/corrected updated: g3; h2; h3; h6 a review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause cannot 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.

• 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: 6411554
• Report Number: 0001825034-2017-01685
• Device Sequence Number: 19083141
• Product Code: PBI
• UDI-Device Identifier: 00880304527133
• UDI-Public: (01)00880304527133(10)3123575(17)180905
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/03/2022
• 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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: 08/03/2017; 03/23/2022; 05/02/2022
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 08/08/2017; 04/14/2022; 05/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male