MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER FEM HD 28/0MM T1; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately one year and five months post right total hip arthroscopy, the patient developed pain and had a disassociation.There was no additional information available related to the initial disassociation.Subsequently, approximately one month ago, the patient presented to the emergency department with a dislocation.The head was relocated; however, the x-ray showed a disassociation.The patient was revised and during the procedure, a large amount of metallosis with some damage to the neck of the stem was noted.The head was observed to have significant metal debris and had disassociated from the bearing.The bearing showed damage and was floating in soft tissue.Wear was also noted to the liner, which made it difficult to remove.The stem neck was found to be impinging on the liner rim.Further damage was caused during removal, as the suction cup and vibration techniques failed.An osteotome was used to remove the damaged liner.The surgeon decided that further constraint was required due to the soft tissue damage caused by the metallosis.Extensive debridement was made, and the head and liner were inserted, and the stem was revised.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign: country: australia.D10: cat# ep-200146; lot# 65852208; act artic e1 hip brg 28x40mm.Cat# 110024462; lot# 65891821; g7 dual mobility liner 40mm d.Cat# 51-149050; lot# 7334570; tprlc xr mp fp t1 pps 5x95mm.Cat# 1100010243; lot# 7464662; g7 osseoti 3 hole shell 50mm d.Investigation of this incident is currently ongoing.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, 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/radiographs were provided and reviewed by a healthcare professional/radiologist.The review identified a right hip arthroplasty with eccentric position of the femoral head in relation to the acetabular cup consistent with disassociation of the polyethylene component.Implant fit is maintained.There is malalignment secondary to polyethylene liner displacement with resulting eccentric femoral head position.Bone quality is osteopenic.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.
Event or Problem Description
No further event information available at the time of this report.
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 head was evaluated.Upon visual inspection, the od of the head has wear damage along with a scratch on the lip.This is visually consistent with metal transfer.The inside taper also has marking lines on the surface also visually consistent with metal transfer.The height and width of the head were checked and found to be in conformance to the print.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: BIOLOX DELTA CER FEM HD 28/0MM T1
• Common Device Name: HIP PROSTHESIS
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20254751
• Report Number: 3002806535-2024-00378
• Device Sequence Number: 7415282
• Product Code: LZO
• UDI-Device Identifier: 00887868271526
• UDI-Public: (01)00887868271526(17)330327(10)3149925
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 01/03/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 650-1158
• Device Lot Number: 3149925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 12/06/2024; 01/02/2025
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 12/06/2024; 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 96 KG