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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Rash (2033); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 03/26/2023

Event Type  Injury  

Event Description

It was reported that a patient had an initial left total hip arthroplasty.Approximately 11 days post-op, they developed an ipsilateral rash, pain, and swelling to the calf and was diagnosed with a dvt.The patient was placed on xarelto and considered resolved 4 months later.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10: ref (b)(4), lot 7384978 cup pressfit, g7 7 hole, pps 52 od.Ref (b)(4), lot 65574750 liner g7 vivacet -e 36mm, sz e.Ref (b)(4), lot 3137141 biolox delta ceramic head 36/3.5.Ref (b)(4), lot 3129306 stem avenir complete cementless 130.Ref (b)(4), lot j7423214 screw 6.5mm x 30mm.Ref (b)(4), lot j7373545 screw 6.5mm x 20mm.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

No additional information at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: g3; h2; h3; h6.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.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14
• Type of Device: 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: 18266145
• MDR Text Key: 329723375
• Report Number: 0009613350-2023-00662
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430372
• UDI-Public: (01)00889024430372(17)321115(10)3137141
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877503603
• Device Lot Number: 3137141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White