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

Model Number N/A

Device Problems Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Ossification (1428); Failure of Implant (1924)

Event Date 06/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).The device will not be returned for analysis, as the device location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that patient underwent hip arthroplasty and was subsequently revised approximately 9 (nine) years later due to loosening of the cup, bone remodeling, and wear.The cup, head, and bearing were exchanged without complications.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.No product was returned; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: acetabular detachment, cup/bearing wear, no other complications noted.Part and lot identification are necessary for review of device history records, neither were provided.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.

• Brand Name: UNKNOWN ARCOM XL CUP
• Type of Device: PROSTHESIS, 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: 15978532
• MDR Text Key: 305490262
• Report Number: 0001825034-2022-02786
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

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
• 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: 11/25/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 01/17/2023
• 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: UNKNOWN BEARING; UNKNOWN CEMENT; UNKNOWN SIZE +3/32 HEAD; UNKNOWN SIZE 2 STEM
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Weight: 78 KG