MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER OPTION HD 28MM; HIP PROSTHESIS

Catalog Number	650-1055
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Rash (2033); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, post-implantation, the patient alleged experiencing multiple issues, including: excruciating pain immediately after surgery; a metallic taste in the mouth (with a corresponding nickel allergy); a rash on the leg; sensations of femoral shifting; two rounds of antibiotic treatment plus iv antibiotics for infection; limited mobility; numbness in the toes when lying on the side; heart attack¿like symptoms; back pain; potassium and magnesium infusions for an unknown reason, which reportedly made them feel worse; alleged passage of a 5 mm piece of metal in the urine (which the surgeon stated was most likely a kidney stone); and other green particles in the urine, suspected to be suture material.Attempts have been made to obtain additional information; however, no further details have been provided.
Additional Manufacturer Narrative
(b)(4) d10 - associated medical devices: cer option type 1 tpr sleve -3; item# 650-1065; lot# 3048758, g7 pps ltd acet shell 54f; item# 010000664; lot# 7035252, g7 dual mobility liner 44mm f; item# 110024464; lot# 370560, tprlc 133 mp type1 pps ho 11.0; item# 51-107110; lot# 6883354, vivacit-e dm bearing 28x44mm; item# 110031012; lot# 7035252, bone screw self-tapping 6.5 mm dia.40 mm length; item# 00625006540; lot# 64934263.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 information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10, h11.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.Review of complaint histories identified additional similar complaints for the reported items and no additional complaints for the reported part and lot combination.Complaints are monitored per complaint trending process.Review of complaint history found no additional related issues for this item and the reported part and lot combination.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 is available at the time of this report.

• Brand Name: BIOLOX DELTA CER OPTION HD 28MM
• Common Device Name: HIP PROSTHESIS
• 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: 22837754
• Report Number: 3002806535-2025-00351
• Device Sequence Number: 21187952
• Product Code: LZO
• UDI-Device Identifier: 00887868271373
• UDI-Public: (01)00887868271373(17)300428(10)3031481
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: 650-1055
• Device Lot Number: 3031481
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female