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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report: source: (b)(6).Concomitant medical products: catalog number:010000705 lot number:3818257 brand name: g7 bonemaster shell.Catalog number:010000936 lot number:3819969 brand name: g7 hi-wall e1 liner.Catalog number:51-110100 lot number:3581766 brand name: taperloc stem.Catalog number:650-0661 lot number: 2016050122 brand name: biolox head.Multiple reports were submitted along with this report 0001825034-2021-03217, 0001825034-2021-03219.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.Device remians implanted in the patient.
Event or Problem Description
It was reported that the patient experienced pain approximately 5 years post implantation.However, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was additionally reported that medication was provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were.Updated: a4, b7, b4, b5, g3, h1, h2, h3, h6, h10.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: primary op notes were reviewed and no complications were noted.Patient-reported pain with right lateral aspect of the trochanter area of surgical approach has discomfort provided otc joint rub.X-rays good position of right tha, no evidence of subsidence or loosening of components and are in good position radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: anatomic alignment of the right hip arthroplasty.Minimal heterotopic ossification.Small avulsed enthesophyte at the hip abductor attachment to the greater trochanter.Reported event was confirmed by review of medical records provided.Review of the device history records identified no deviations or anomalies during manufacturing.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.

• Brand Name: G7 HI-WALL E1 LINER 36MM F
• 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: 12908864
• Report Number: 0001825034-2021-03218
• Device Sequence Number: 20038840
• Product Code: PBI
• UDI-Device Identifier: 00880304527119
• UDI-Public: (01)00880304527119(17)210613(10)3819969
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2021
• Device Model Number: N/A
• Device Catalogue Number: 010000936
• Device Lot Number: 3819969
• 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: 11/22/2021
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2016
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG