MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM COCR MOD HD +9MM; PROTHESIS, HIP

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Arthritis (1723); Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)

Event Date 06/28/2021

Event Type  Injury  

Event Description

It was reported the patient underwent an initial left total hip arthroplasty.Four years post implantation the patient was revised due to dislocation.It was noted during the revision the patient had instability posteriorly, tissue damage to the posterior capsule, and bone loss.The stem remained implanted.A second revision took place nine years later due to metallosis from trunnion wear.During the revision noted large amount of cloudy yellow fluid, metal debris, cystic changes to greater trochanter, and no vascularity to acetabulum and femur.All components were exchanged with competitor product and a competitor cerclage wire to the greater trochanter as a preventive measure due to thin bone.

Manufacturer Narrative

(b)(4).D10: cp156354 mclaughlin acet 54mm lnr sz 24 884760.103534 ti low profile screw 6.5x35mm 619270.Ep-105894 epoly rlc 36mm 10deg sz24 sz24 231250.X180312 bi-metric/x por nc 12x140 336810.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01036.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on evaluation of medical records.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: metallosis from trunnion wear.Head removed, noted metal debris to trunnion and head.Cystic changes to greater trochanter.A definitive root cause cannot be determined.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 Description

No additional event information to report at this time.

• Brand Name: 36MM COCR MOD HD +9MM
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16918310
• MDR Text Key: 315072214
• Report Number: 0001825034-2023-01030
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

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 Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 11-363665
• Device Lot Number: 943960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2010
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female