MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CERAMIC FEM HD 36/+3MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	650-0662
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Necrosis (1971); Pain (1994); Subluxation (4525); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 ¿ (b)(6), lot 6911117, g7 pps ltd acet shell 56f.(b)(6), lot 6238870, tprlc xr t1 pps 18x156mm.(b)(6), lot 64849786, 36mm i.D.Size f +5mm offset liner.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 by legal that a patient had an initial right total hip arthroplasty performed approximately four years and three months ago.The patient did well until two years postop when he was moving a box and leaning forward and felt something pop in his hip.Immediate x-rays did not show any acute findings.Three weeks later, the patient presented with progressive pain, squeaking, swelling, and redness in the hip.X-rays showed the femoral head articulating against the cup with poly liner dissociation and subsidence.Elevated crp levels increased concern for infection, so the patient underwent irrigation and debridement with head and liner exchange approximately rwo years ago.During the revision, significant metallosis was identified through a tear in the fascia which tracked down into the hip.Necrotic tissue and pieces of loose poly were removed from the hip.The hip was thoroughly irrigated, and a new head and liner were placed without complications.The initial stem and shell were well positioned and remained intact.Follow up six months post-revision demonstrated full recovery without complications.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b7, g3, g6, h2, h11.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 information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.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.Medical records were provided and reviewed by a health care professional.Review of the available records confirmed the reported event.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 information is available at the time of this report.

• Brand Name: BIOLOX DELTA CERAMIC FEM HD 36/+3MM
• 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 CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23356500
• Report Number: 3002806535-2025-00507
• Device Sequence Number: 8872011
• Product Code: LZO
• UDI-Device Identifier: 00887868271182
• UDI-Public: (01)00887868271182(17)301106(10)3043983
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2026

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: 650-0662
• Device Lot Number: 3043983
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 10/30/2025; 03/17/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/27/2025; 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White