MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CONTINUUM CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unequal Limb Length (4534)

Event Date 10/09/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 01672.D10: unknown durom cup, unknown metasul head.G2: foreign: italy.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a right total hip arthroplasty that was subsequently revised approximately 5 years later due to loosening of the acetabular cup.Following the revision, the patient continued to demonstrate elevated serum cobalt and chromium levels, pain, difficulty, limited range of motion, leg length discrepancy, and radiolucency at the cup and stem regions with areas of decreased bone density at the distal end of the stem.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.Subsequently a revision occurred due to loosening of the cup.Post-revision, the patient is continuing to experience elevated metal ions and pain.X-rays show radiolucency at the stem and the cup.A definitive root cause cannot be determined.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

No further information at the time of this report.

• Brand Name: UNKNOWN CONTINUUM CUP
• Type of Device: 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: 17180924
• MDR Text Key: 317637648
• Report Number: 0001822565-2023-01671
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN CONTINUUM CUP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/30/2023
• 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: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 80 KG