MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE E NEUTRAL LINER; PROSTHESIS, HIP

Catalog Number	20103605
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a clinical study, at the 2 year follow-up appointment, the patient had been experiencing groin pain that radiates to the lateral hip for the last three months.So far, the patient has been treated through pain management clinic visits with narcotic pain medication and multiple unknown injects that results in temporary pain relief.Attempts have been made but no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: cat #: 00625006530 / bone screw self-tapping 6.5 mm dia.30 mm length / lot #: j7180079 unknown apical hole plug; cat #: 010000663 / g7 pps ltd acet shell 52e / lot #: 7205831; cat #: 51-104130 / tprlc 133 t1 pps ho 13x146mm / lot #: 7062049; cat #: 650-0662 / delta ceramic fem hd 36/+3mm / lot #: 3095589.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-02120, 0001825034-2024-01679, 0001825034-2024-01680, 3002806535-2024-00235.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: mobility issues and pain with temporary relief due to medication.An mri was performed and the patient was confirmed to have no loosening, infection, malalignment, or surrounding fluid collection.The complaint is confirmed based on the evaluation of the provided medical records.Dhr was reviewed and no discrepancies related to the reported event were found.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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: 36MM I.D. SIZE E NEUTRAL LINER
• Common Device Name: PROSTHESIS, 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: 19605531
• Report Number: 0001822565-2024-02119
• Device Sequence Number: 12370627
• Product Code: LPH
• UDI-Device Identifier: 00889024518742
• UDI-Public: (01)00889024518742(17)270120(10)65255952
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/30/2024

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 Catalogue Number: 20103605
• Device Lot Number: 65255952
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White