MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/-3MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	650-0660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure 2 years and 27 days post implantation due to infection.It was noted that the cup was not well fixed.A washout was performed with an exchange of the head and liner.Five screws were also explanted.Surgeon decided all metalware needed to be removed and a girdle stones hip was to remain for future assessment and management of the infection.A well fixed arcos sts/cone was removed via eto.Tissue samples taken and wound closed.There is no additional information available at the time of this report.It was reported that the patient underwent revision surgery due to infection.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).G2-foreign-australia.D10.Item#:11-301332 ;lot#:409820 ;item name:arcos con sz b hi 70mm; item#:11-300816 ;lot#:791480 ;item name:arcos 16x150mm spl tpr dist; item#:00620206420 ;lot#:62526380 ;item name:arcos 16x150mm spl tpr dist ; item#:00631006436 ;lot#:63631271 ;item name:liner 10 degree elevated rim 3.5 mm offset 36 mm i.D.For use with 64 mm o.D.Shell ; item#:hip-unk-screws ;lot#:unknown ;item name:hip-unk-screws, qty x 5 ; investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
Upon review of this complaint from an investigation perspective, it is now considered that the delta ceramic femoral head within this complaint does not impact the reported event of infection.Hence this report will be voided.
Additional Manufacturer Narrative
(b)(4).Upon review of this complaint from an investigation perspective, it is now considered that the delta ceramic femoral head within this complaint does not impact the reported event of infection.Hence this report will be voided.Given the above information this medwatch will be voided.

• Brand Name: DELTA CERAMIC FEM HD 36/-3MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 17643117
• Report Number: 3002806535-2023-00292
• Device Sequence Number: 12160254
• Product Code: LZO
• UDI-Device Identifier: 00887868271168
• UDI-Public: (01)00887868271168(17)290916(10)2019090722
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 10/19/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 650-0660
• Device Lot Number: 2019090722
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male