MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA HEAD 12/14 36X0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number N/A

Device Problems Failure to Osseointegrate (1863); Patient-Device Incompatibility (2682); Osseointegration Problem (3003)

Patient Problems Ossification (1428); Seroma (2069); Subclinical Infection (2247); Muscle/Tendon Damage (4532)

Event Date 10/18/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery approximately one (1) month post implantation due to infection and defects in the iliotibial band with heterotopic ossification and granulation tissue.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10 ¿ associated products: item #00-7713-012-00 item name #modular femoral stem press-fit plasma sprayed cementless size 12.5 lot #61265772.Item #00-7848-022-00 item name #modular neck b 12/14 neck taper use with +0 heads only lot #65376852.Item #00-6305-056-36 item name #liner standard 3.5 mm offset 36 mm i.D.For use with 56 mm o.D.Shell lot #65249106.Item #00-6250-065-25 item name #bone screw self-tapping 6.5 mm dia.25 mm length lot #61288013.Item #00-6200-056-22 item name #shell porous with cluster holes 56 mm o.D.Lot #61237887.Item #00-6201-056-00 item name #replacement locking ring for use with 56 mm shell lot #62683780.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

Upon reassessment of the reported event, it was determined a medwatch report should not have been filed because implanted products are not identified as the source or contributing to the reported infection.Given this information, this medwatch will be voided.

Manufacturer Narrative

The following sections were updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, h10.A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery.This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.As this fluid collects, it can elicit an immune response or develop an infectious process.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Heterotopic ossification (ho) is the abnormal and rapid growth of bone that forms within soft tissue as the result of heredity, trauma, surgical history, or diseases of a joint.The rapid and irregular growth of bone often causes a sharp or jutted structure to form, which can result in pain and irritation to the surrounding tissues, or the patient can remain asymptomatic.Radiation or nonsteroidal anti-inflammatory medications are often provided to prevent ho formation.The only treatment, if necessary, is surgical excision or shaving/smoothing out the excess bone.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.Upon reassessment of the reported event, it was determined a medwatch report should not have been filed because implanted products are not identified as the source or contributing to the reported infection.Given this information, this medwatch will be voided.

• Brand Name: BIOLOX DELTA HEAD 12/14 36X0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 17331791
• MDR Text Key: 319285155
• Report Number: 0009613350-2023-00388
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)320127(10)3101756
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-02
• Device Lot Number: 3101756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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 H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male