MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 36/-3.5, TAPER 12/14; HIP IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: g7 pps ltd acet shell 50d item #010000662 lot #r7304614a.G7 vit e neutral lnr 36mm d item # 30103604 lot #65627113.Avenir cmpl ha std col size 4 item #574201040 lot #3060082.Bone scr 6.5x25 self-tap item #00625006525 lot # j7375825.Bone scr 6.5x25 self-tap item #00625006525 lot # j7375821.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that 23 days post-implantation, the patient was diagnosed with a dvt in their right leg.The patient was placed on oral anticoagulant treatment and the complication resolved.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 information.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Deep vein thrombosis (blood clot), or dvt, occurs when a blood clot forms in one of the deep veins of the body.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operatively to prevent dvt formation.Even with the administration of preventive medication, dvts can still develop.As the complaint indicated, a post-operative complication occurred, and medical intervention was required for treatment.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 additional information at this time.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 36/-3.5, TAPER 12/14
• Common Device Name: HIP IMPLANT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18266451
• Report Number: 0009613350-2023-00671
• Device Sequence Number: 7840521
• Product Code: LZO
• UDI-Device Identifier: 00889024430358
• UDI-Public: (01)00889024430358(17)320608(10)3115418
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 01/03/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877503601
• Device Lot Number: 3115418
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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: Other
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White