MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 28MM -3 NK; BIOLOX DELTA CERAMIC OPTION HD

Model Number	N/A
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that: a patient underwent left tha on (b)(6) 2019 by (b)(6).Subsequently, a revision procedure of left tha due to aseptic loosening of the femoral stem by (b)(6) was performed on (b)(6) 2022.Findings: (b)(6) 2021; office visit.Contralateral hip performed (b)(6) 2021.Follow up visit for right tha which is doing well; left hip increasing pain with ambulation, now using a cane.X-ray: overall well aligned, some areas of radiolucencies with scalloping around the femoral stem.Plan for left hip revision.On (b)(6) 2022; revision.Revision due to aseptic loosening; no ingrowth of the femoral stem noted; shell well fixed and left in place; arcos stem attempted but surgeon not satisfied with the position, wagner used instead; head and stem replaced without complications.
Additional Manufacturer Narrative
(b)(4).Initial report.The client has indicated that the product will not be returned to zimmer biomet for an investigation.Associated products: medical product: act artic e1 hip brg 28x42mm s48 dia28; catalogue number: ep-200148; lot number: 560940.Medical product: tprlc 133 t1 pps ho 11x142mm 2mm t1; catalogue number: 51-104110; lot number: 6551317.Medical product: g7 dual mobility liner 42mm e; catalogue number: 110024463; lot number: 948540.Medical product: g7 osseoti 3 hole shell 52mm e; catalogue number: 110010244; lot number: 6601603.Medical product: bone screw self-tapping 6.5 mm dia.30 mm length; catalogue number: 00625006530; lot number: 64495274.Medical product: bone screw self-tapping 6.5 mm dia.30 mm length; catalogue number: 00625006530; lot number: 64563153.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.Discarded.
Event or Problem Description
Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.
Additional Manufacturer Narrative
Upon review of this complaint, it is considered that the ceramic head does not impact the reported event of aseptic loosening of the femoral stem and is already featured as an associated product on the linked warsaw complaint.Event is no longer considered reportable, and initial report should be voided.

• Brand Name: CER BIOLOXD MOD HD 28MM -3 NK
• Common Device Name: BIOLOX DELTA CERAMIC OPTION HD
• 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: 13800382
• Report Number: 3002806535-2022-00112
• Device Sequence Number: 17116718
• Product Code: LZO
• UDI-Device Identifier: 00887868248405
• UDI-Public: 00887868248405
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K051411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 12-115109
• Device Lot Number: 2983045
• 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: 02/16/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEEH10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 29 KG