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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item reference:30103605, item name:g7 vit e neutral lnr 36mm e, lot number: 65516876.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that patient underwent revision due to ceramic head fracture, 2 weeks post op.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10: associated devices: reference number: (b)(4), item name: tprlc 133 t1 pps ho 12x144mm, lot number: 6992221 reference number: (b)(4), item name: g7 pps ltd acet shell 52e, lot number: 7311439 visual examination of the returned product identified that the ceramic head was returned in 3 pieces and not all of the ceramic head is returned.The poly liner was also returned in 3 pieces and not all of the poly liner was returned.There are tiny fragments of the ceramic head still in the poly liner.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Medical records were provided.Images assessed and not sent to mmi for images are fluoroscopy indicating intra-operative images and would not add value to the complaint.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 information.Medical records were provided and reviewed by a health care professional.Revision due to fractured femoral head and poly damage.Felt a ¿clunk¿ while reaching for the cupboard, reports no trauma winter 2022 evaluation showed what appeared to be a fractured ceramic head.Fractured ceramic femoral head into 3 pieces with poly damage.Acetabular and femoral stem component were well aligned and well fixed.Supplemented acetabular fixation with a screw.Excellent stability and reproduction of leg length noted.No intraoperative complications reported.With the available information, a definitive root cause could not be determined.No change to the outcome of the investigation.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
Initial left total hip arthroplasty performed in the late autumn 2022.Subsequently, in the winter 2022 the patient was revised due to fractured femoral head with poly damage.During the revision the acetabular and femoral stem components were found to be well aligned and well fixed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A supplier failure analysis was performed which states that no conclusion could be drawn regarding a possible cause for the fracture of the femoral head from the provided ceramic head fragments.There was no indication of a pre-existing material issue.Material analysis of metal transfer seen concluded remnants of iron and chromium which may have been caused by instruments and remnants of titanium which may be from the stem.The precise position of the fracture origin cannot be determined due to secondary damage.It was noted that the primary metals transfer could not be found equally distributed on the conical bore surface of the femoral head, which may indicate that the interface was 'disturbed' during the assembly of the femoral head and metal stem, potentially caused by contaminants.This 'disturbance' can lead to a decrease of the burst strength of the femoral head.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: BIOLOX DELTA MODULAR CERAMIC FEM HD 36/+3MM
• Common Device Name: PROSTHESIS, HIP
• 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: 16003243
• Report Number: 3002806535-2022-00512
• Device Sequence Number: 6679216
• Product Code: LZO
• UDI-Device Identifier: 00887868271182
• UDI-Public: (01)00887868271182(17)320701(10)3119039
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/26/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-0662
• Device Lot Number: 3119039
• 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: 12/07/2022
• Supplement Date Received by Manufacturer: 01/26/2023; 11/01/2023; 12/07/2023; 04/25/2024
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 01/27/2023; 11/21/2023; 12/12/2023; 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male