MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA OPTION CERAMIC HEAD 36MM; PROSTHESIS, HIP

Catalog Number 650-1057

Device Problem Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10.Item#:650-1057 ;lot#: 3161043;item name: cer bioloxd option hd 36mm; item#:30103607 ;lot#: 65967765;item name: g7 vit e neutral lnr 36mm g; item#:650-1066 ;lot#: 3115067;item name: cer opt type 1 tpr sleve 0mm; item#:650-1057 ;lot#:3158159 ;item name: cer bioloxd option hd 36mm; item#:unknown impactor ;lot#:unknown ;item name: unknown impactor ; multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00413.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that when impacting a femoral head onto the stem, it was observed that the head was damaged due to being scratched.Another femoral head was opened, impacted onto the stem and it also was damaged.It was believed that the head impactor was damaged and left scratches.This event is related to a malfunction that could potentially lead to serious injury.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned products confirmed both heads have marks to the outside diameter.Both heads exhibit metal transfer within their tapers indicating that they have been impacted during surgery.One head also has metal transfer on the lip of the device likely from the removal tool when it was removed to be replaced during surgery.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.Medical records were not provided.With the available information, a definitive root cause could not be determined however the surgeon states in the complaint that the head impactor was damaged and left the scratches.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 Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d1, g3, g6, h1, h2, h6, h11.The analysis of information provided by a third party does not alter the findings of the previously reported 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.

• Brand Name: BIOLOX DELTA OPTION CERAMIC HEAD 36MM
• Type of Device: 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: 18272538
• MDR Text Key: 329778290
• Report Number: 3002806535-2023-00412
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 650-1057
• Device Lot Number: 3156908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/04/2024; 04/15/2024
• Supplement Dates FDA Received: 01/18/2024; 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 115 KG