MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HEAD 12/14 36X0; HIP PROSTHESIS

Catalog Number	00-8775-036-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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 a patient had an initial right total hip arthroplasty performed.Subsequently, at the 2 year visit, the patient reported snapping in the hip.Clinic notes indicate that the patient is experiencing iliopsoas tendinitis which occurs when the patient¿s hip is in an extreme rotated position from possible cup or liner impingement.Patient was instructed to avoid extreme positions.Patient was referred for an injection under fluoroscopy.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: g7 osseoti multihole, #item110010265, #lot 65320756, bone screw self-tapping, #item 00625006535, #lot j7273829, bone screw self-tapping, #item 00625006525, #lot j7290883, 36mm i.D.Size f high wall liner, #item 20123606, #lot 65454289, femoral stem press-fit, #item 00786401320, #lot 62868563.Therapy date: (b)(6) 2024.Attempts have been made to gather all product identification information and no further information has been provided.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.A review of the raw material certificate confirmed no abnormalities or deviations.The reported products were reviewed for compatibility with no issues noted.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Medical records were provided and reviewed by a health care professional.The review identified a component of right iliopsoas tendinitis.The patient reports intermittent snapping, 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.A definitive root cause could not 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 information.

• Brand Name: BIOLOX DELTA HEAD 12/14 36X0
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22887417
• Report Number: 0009613350-2025-00669
• Device Sequence Number: 8918973
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)320216(10)3103706
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• 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): 01/13/2026

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 Catalogue Number: 00-8775-036-02
• Device Lot Number: 3103706
• 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: 01/09/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 107 KG