MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM E; PROSTHESIS, HIP

Catalog Number	010000935
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient developed severe pain requiring medication approximately two years post implantation.Upon receipt of the medication, the issue was resolved approximately one month later.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01159, 0001825034-2023-01161.D10: cat #: 110010244 / g7 osseoti 3 hole shell 52mm e / lot #: 6424109; cat #: 193111 / echo b-mtrc mp fp ho 11 / lot #: 163920; cat #: 12-115121 / cer bioloxd mod hd 36mm std nk / lot #: 2971283.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
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.The complaint is confirmed based on the provided medical records.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.

• Brand Name: G7 HI-WALL E1 LINER 36MM E
• 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: 16983064
• Report Number: 0001825034-2023-01160
• Device Sequence Number: 20565863
• Product Code: MBI
• UDI-Device Identifier: 00880304527102
• UDI-Public: (01)00880304527102(17)230905(10)6374859
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2023
• Device Catalogue Number: 010000935
• Device Lot Number: 6374859
• 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: 05/01/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 114 KG
• Patient Race: White