MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/+3MM; HIP PROSTHESIS

Catalog Number	650-0662
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Hematoma (1884); Pain (1994); Joint Dislocation (2374); Respiratory Failure (2484)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial left total hip arthroplasty.One year and three months post implantation, the head and stem were revised due to loosening of the femoral component with failure to osteointegrate.Five years and five months post the first revision procedure, the patient was revised for a second time due to a fracture of the revision stem with complicated extraction via extended trochanteric osteotomy.After the second revision, the patient experienced recurrent dislocations requiring closed reduction under anesthesia.A third revision was planned but delayed due to difficulty extubating the patient and the concurrent onset bilateral pulmonary embolisms.After the patient¿s pulmonary function and anticoagulation measures were stabilized, the revision occurred during which, multiple hematomas were evacuated from the joint, and posterior instability was confirmed on exam.Upon replacing the acetabular shell, anteversion was increased by 15 degrees.A new constrained head and liner were placed within the shell, and the revision stem was retained.Postoperatively, the patient demonstrated slow but steady progress with intensive physical therapy.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: liner standard 3.5 mm offset 36 mm i.D.For use with 56 mm o.D.Shell; item# 00630505636; lot# 63687030.Shell porous with cluster holes 56 mm o.D.; item# 00620005622; lot# 62954811.Bone screw self-tapping 6.5 mm dia.50 mm length; item# 00625006550; lot# 63003489.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
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 information.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.Medical records were provided and reviewed by a health care professional.The review identified the following contributing factors of the event: femur fracture which increases risk for blood clot formation, recurrent dislocations with closed reduction can cause/contribute to hematoma/clot formation during manipulation and sedation, morbid obesity.With the available information, 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 CERAMIC FEM HD 36/+3MM
• 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: 18835517
• Report Number: 3002806535-2024-00080
• Device Sequence Number: 18025735
• Product Code: LZO
• UDI-Device Identifier: 00887868271182
• UDI-Public: (01)00887868271182(17)301222(10)3053017
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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 Catalogue Number: 650-0662
• Device Lot Number: 3053017
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2020
• 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 H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 145 KG
• Patient Race: White