MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/+3MM T1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	650-1161
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item name# g7 pps ltd acet shell 52e; item number# 010000663; lot # 7666473 item name# tprlc 133 t1 pps ho 12x144mm; item number# 51-104120; lot # j7540534 item name# g7 longevity neutral 32mm e; item number# 20103205; lot # 64878487 g2: foreign - event occurred in netherlands.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.
Event or Problem Description
It was reported that approximately seven months post left hip implantation, the patient received treatment for pain in their left thigh.Following long walks, there is radiating stabbing pain from buttocks down the thigh and knee.The patient has received a cortisone injection for pain in the left bursa.The patient undergoes weekly physical therapy, massage, and exercises.Six months later, the patient reported mild pain with little difficulties and no required pain medication.Attempts have been made, and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
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, e2, g3, g6, h2, h3, h6, h11.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.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.The review identified that the patient reports left thigh pain after prolonged walking, described as stabbing pain radiating from the buttock to the thigh and knee.Management to date includes weekly physiotherapy, massage, and exercises.A cortisone injection was administered to the left bursa.One year post op, the patient is able to walk painlessly after the most recent injection.Imaging: the x-ray is stable and shows no current abnormalities.The left uncemented total hip prosthesis appears unchanged, with no demarcation and no periarticular soft tissue abnormalities.The right hip also shows no current abnormalities.Overall impression persistent activity-related left-sided pain is reported despite conservative treatment, while imaging does not show an obvious prosthesis-related abnormality.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DELTA CER FEM HD 32/+3MM T1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24065742
• Report Number: 3002806535-2026-00019
• Device Sequence Number: 9387587
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: 650-1161
• Device Lot Number: 3189575
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 159 LB