MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIVACIT-E 36MM I.D. SIZE F NEUTRAL LINER; PROTHESIS, 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	07/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately one and a half years post implantation of a total hip arthroplasty, the patient was revised due to unexplained pain.The modular neck, head and liner were replaced.There were no contributing conditions related to the event.Surgical technique was utilized.No additional information available.
Additional Manufacturer Narrative
(b)(4).G2: foreign: country: japan.D10: cat# 00784803300 lot# 63958271 modular neck c 12/14 cat# 00-8775-036-02 lot# 3133344 biolox delta head 12/14 36x0 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d4;g3;h2;h3;h4;h6.The product was not returned for evaluation.However, pictures were proved and reviewed.A visual examination of the provided pictures identified the explanted neck and liner.The pictures of the liner appeared to show surface damage on the face of the liner; it is unknown when the surface damaged occurred.No further evaluations can be made from the pictures provided.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.A definitive root cause cannot be determined.The complaint cannot be confirmed.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 report: 0001822565-2024-02511.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: G7 VIVACIT-E 36MM I.D. SIZE F NEUTRAL LINER
• Common Device Name: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19867223
• Report Number: 0001822565-2024-02510
• Device Sequence Number: 7513570
• Product Code: LPH
• UDI-Device Identifier: 00889024519916
• UDI-Public: (01)00889024519916(17)270607(10)65487494
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: 30103606
• Device Lot Number: 65487494
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown