MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/0MM T1; PROSTHESIS, HIP

Catalog Number 650-1162

Device Problem Fracture (1260)

Patient Problems Ossification (1428); Failure of Implant (1924)

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2-foreign-belgium.D10.Item#: unknown; lot#: unknown; item name: unknown liner; item#: unknown; lot#: unknown; item name: unknown shell; item#: unknown; lot#: unknown; item name: unknown taperloc stem biomet; multiple mdr reports were filed for this event, please see the associated reports: 3002806535 - 2023 - 00443, 3002806535 - 2023 - 00444.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 the patient underwent revision surgery due to prosthetic fracture and heterotopic ossification.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

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b7, d9, d10, g3, g6, h2, h3, h11.D10 - associated medical devices: ringloc-x e1 std 50/32mm 23; item# ep-043250; lot# 3103574.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 CER FEM HD 32/0MM T1
• 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: 18354932
• MDR Text Key: 330875783
• Report Number: 3002806535-2023-00437
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271564
• UDI-Public: (01)00887868271564(17)230317(10)3002597
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K200959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/17/2023
• Device Catalogue Number: 650-1162
• Device Lot Number: 3002597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2013
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 83 KG