MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 28/-3MM T1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	650-1159
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a primary total hip replacement and subsequently developed ongoing pain during hip flexion and external rotation, with suspected iliopsoas involvement/impingement.The patient¿s joint was later reopened, and a subsequent procedure was performed approximately 19 months post-implantation.Details regarding specific component changes or intra-operative findings were not provided.No environmental factors were reported.The patient was revised; no further details regarding the patient¿s outcome were provided.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item name# act artic e1 hip brg 28x40mm; item number# ep-200146; lot # 66191003.Unknown cup; item number# unknown; lot # unknown.G2: foreign - event occurred in australia.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d2a, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty.Femoral offset is greater at the right hip arthroplasty compared with the left native hip.Increased femoral offset may be a risk factor for symptoms of iliopsoas impingement.Lack of lateral view limits assessment for other risk factors, such as anterior acetabular cup overhang.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: DELTA CER FEM HD 28/-3MM T1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23704860
• Report Number: 3002806535-2025-00558
• Device Sequence Number: 10641314
• Product Code: LZO
• UDI-Device Identifier: 00887868271533
• UDI-Public: (01)00887868271533(17)320103(10)3093881
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: 650-1159
• Device Lot Number: 3093881
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Female