MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Seroma (2069); Subclinical Infection (2247); Muscle/Tendon Damage (4532)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 01950, 0001822565 - 2023 - 01951.D10: cat# 00877503602 lot# 3101756 bioloxâ® delta, ceramic femoral head, m, 㸠36/0, taper 12/14.Cat# 00625006525 lot# 61288013 bone scr 6.5x25 self-tap.Cat# 00620005622 lot# 61237887 shell porous with cluster holes 56 mm o.D.Cat# 00620105600 lot# 62683780 replacement locking ring for use with 56 mm shell.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.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.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent an initial right total hip arthroplasty revision.After the revision, the patient did very well then presented with sudden onset swelling along the distal incision.As there were no clinical indications of infection, this was thought to be a seroma, and the patient was scheduled for an incision and drainage procedure.During the procedure approximately 1-month post-revision, the area of the seroma had a slight brown tinge in the fluid, but no gross purulence noted.The soft tissues were then debrided which revealed defects in the iliotibial band with heterotopic ossification and granulation tissue.An extensive irrigation and debridement was performed with placement of antibiotic beads.The stem and shell were left in place.All other components were revised without complication.Attempts have been made and no further information has been provided.

• Brand Name: LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17344646
• Report Number: 0001822565-2023-01952
• Device Sequence Number: 6524109
• Product Code: LPH
• UDI-Device Identifier: 00889024123816
• UDI-Public: (01)00889024123816(17)270310(10)65249106
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K182678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00630505636
• Device Lot Number: 65249106
• 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: 06/23/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male