MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 58 MM O.D.; PROTHESIS, HIP

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

Patient Problems Necrosis (1971); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 11/14/2018

Event Type  Injury  

Event Description

It was reported by legal that the patient underwent an initial left total hip arthroplasty.Subsequently, the patient was revised twelve years post implantation due to pain, elevated metal ions, and fluid collection per mri consistent with altr.During the revision, pseudocapsule, osteolysis, and trunnionosis were found.The locking ring not disengagin was also found.The liner, head, and locking ring were exchanged.The shell and stem remained implanted.

Manufacturer Narrative

(b)(4).D10: 00630505832 liner standard 32 mm i.D.For use with 58 mm o.D.Shell 60415629.00784501450 femoral stem fiber metal midcoat collarless 12/14 neck taper extended neck offset cementless size 14 lm body 60298042.00801803203 femoral head sterile product do not resterilize 12/14 taper 60378468.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 01675, 0001822565 - 2023 - 01676, 0001822565 - 2023 - 01677.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

This follow-up report is being submitted to relay additional and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history identified no additional complaints for the shell and no additional complaints for the reported part and lot combinations.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed, and a revision occurred twelve years post implantation due to pain and elevated metal ions.Upon entering the joint, a pseudocapsule was identified, as well as black corrosion to the trunnion and osteolysis.The locking ring would not move freely and was replaced.The head and liner were also explanted and exchanged with no complications noted.A definitive root cause cannot be determined.This complaint was confirmed based on the provided medical records.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: SHELL POROUS WITH CLUSTER HOLES 58 MM O.D.
• Type of Device: PROTHESIS, 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: 17190409
• MDR Text Key: 317737956
• Report Number: 0001822565-2023-01674
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

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: 11/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 00620005822
• Device Lot Number: 60382439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2005
• 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: Male