MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X25 SELF-TAP; PROSTHESIS, HIP

Catalog Number	00625006525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tendinopathy (4887)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 010000662 item name g7 pps ltd acet shell 50d lot # r7304614a.30103604 item name 36mm i.D.Size d neutral liner lot # 65627113.00877503601 item name biolox⮠delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14 lot # 3115418.574201040 item name femoral stem cementless collared standard offset 12/14 taper size 4 lot # 3060082.00625006525 item name bone screw self-tapping 6.5 mm dia.25 mm length lot # j7375825.The device will not be returned for analysis as it was discarded; 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
It was reported that 2 years post implantation, the patient reported mild left hip flexor tendinitis.Patient was prescribed physical therapy and the tendinitis has resolved.There is no further information available at the time of this report.
Additional Manufacturer Narrative
Upon reassessment of the reported event and additional information received, it was determined to be not reportable as the tendonitis was unrelated to the device.The initial report was forwarded in error and should be voided.Sections updated b4 b5 g3 g6 h2 h11.
Event or Problem Description
Upon reassessment of the reported event and additional information received, it was determined to be not reportable as the tendonitis was unrelated to the device.The initial report was forwarded in error and should be voided.

• Brand Name: BONE SCR 6.5X25 SELF-TAP
• 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: 22025345
• Report Number: 0001822565-2025-01416
• Device Sequence Number: 9390695
• Product Code: LPH
• UDI-Device Identifier: 00889024119819
• UDI-Public: (01)00889024119819(17)321025(10)J7375821
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: Lay User/Patient
• Device Catalogue Number: 00625006525
• Device Lot Number: J7375821
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2022
• 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: PLEASE SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White