MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK 48 MM PRESS-FIT CUP; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Patient Device Interaction Problem (4001)

Patient Problems Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00783.0001825034-2022-00784.

Event Description

It was reported the patient underwent a left hip revision approximately 16 years post implantation due to pain, elevated metal ions, trendelenburg lurch, pseudotumor and abductor destruction.During the revision the trochanter was found bald with no abductors attached, no capsule, and appeared dead.Metal debris was inside of head and on the cup with mild trunnionosis.The head was exchanged without complications.The stem and cup remained implanted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed due to the review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: severe bilateral groin pain, trendelenburg lurch, elevated metal ions >50, mri ¿ pseudotumor and abductor destruction.Left hip metal on metal failure, pseudotumor, abductor destruction, trunnionosis.Completely bald trochanter with no abductors attached and with no capsule, greater trochanter appeared dead.Pseudotumor removed along with metal stained tissue.Metal debris inside of head, mild trunnionosis, and metal debris on the cup, trunnion cleaned.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.Upon reassessment of the reported event, the cup was determined to be not reportable as the device is not believed to have caused or contributed to the event.The initial report was forwarded in error and should be voided.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 Description

Upon reassessment of the reported event, the cup was determined to be not reportable as the device is not believed to have caused or contributed to the event.The initial report was forwarded in error and should be voided.

• Brand Name: UNK 48 MM PRESS-FIT CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13976445
• MDR Text Key: 288374376
• Report Number: 0001825034-2022-00785
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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: 05/09/2022

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: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNK 12.5 MM TAPER LOCK STEM; UNK 38 MM COBALT-CHROME HEAD
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female