MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW SELF-TAPPING 6.5 MM; PROSTHESIS, HIP

Catalog Number	00625006535
Medical Device Problem Codes	Unintended Movement (3026); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834); Tendinopathy (4887)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced snapping in the hip approximately two years post-implantation.It was confirmed that the patient had iliopsoas tendinitis caused by impingement.Patient was referred for an injection under fluoroscopy.Follow-ups to gather additional information are currently in process.
Additional Manufacturer Narrative
(b)(4).D10: g7 osseoti multihole 54mm f.Item: 110010265.Lot: 65320756.Bone scr 6.5x25 self-tap.00625006525.J7290883.Bioloxâ® delta, ceramic femoral head.00877503602.3103706.Femoral stem press-fit collarless 12/14 neck taper.00786401320.62868563.The customer has indicated that the product remains implanted and will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient had an initial right tha in august 2022.At 6 weeks postop, patient reported mild pain, limp and difficulties.Follow ups for 1 year and 2-year post op, found no pain and no complications radiographically.At 2 years post op, it was identified psoas tendinitis and was referred for tendon injection under flouro.The patient reports intermittent snapping in the hip, tenderness in hip flexor muscles and pain with flexion.X-rays show no loosening, wear or lysis.Clinical notes suggest patient has iliopsoas tendinitis on the right which occurs when the hip is placed in extreme rotational positions.This may be related to impingement against the acetabular cup or liner.It was discussed that he should avoid extreme hip positions.The surgeon will arrange a right iliopsoas tendon injection under fluoroscopic guidance.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.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 trends.
Event or Problem Description
No additional information available for the reported event.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM
• 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: 22890474
• Report Number: 0001822565-2025-03089
• Device Sequence Number: 8984961
• Product Code: LPH
• UDI-Device Identifier: 00889024119833
• UDI-Public: (01)00889024119833(17)320609(10)J7273829
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00625006535
• Device Lot Number: J7273829
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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
• 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 H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 107 KG