MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI LOW PROFILE SCREW 6.5X30MM; PROSTHESIS, HIP

Catalog Number	103533
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Bursitis (4832)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had an initial right total hip arthroplasty.Subsequently, the patient was revised approximately 6 years later due to pain and slightly elevated chromium levels.The initial stem was left intact while all other components were replaced without complications.After the revision, the patient reported ongoing pain in bilateral hips.The surgeon stated he felt the patient had bilateral hip trochanteric bursitis and discussed injections with the patient; however, the patient declined treatment and interventions.The patient takes chronic opioids and is followed by pain management for polyarthralgia.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).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 3500a will be submitted.

• Brand Name: TI LOW PROFILE SCREW 6.5X30MM
• 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: 25796234
• Report Number: 0001825034-2026-02043
• Device Sequence Number: 15716886
• Product Code: KWA
• UDI-Device Identifier: 00880304008700
• UDI-Public: (01)00880304008700(17)250526(10)082600
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K082446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2026

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 Expiration Date: 05/26/2025
• Device Catalogue Number: 103533
• Device Lot Number: 082600
• 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: 06/18/2026
• Initial Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: Black Or African American