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

Model Number N/A

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision due to unknown reasons.However, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown liner; unknown stem; unknown head.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 information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.A definitive root cause cannot be determined for the reported infection.An off-label use was identified, as a stryker stem was used in conjunction with zimmer biomet products.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

It was reported that the patient underwent a revision procedure of the right acetabulum on an unknown date due to infection.The stem was a stryker system.No further event information available at the time of this report.

• Brand Name: UNKNOWN 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: 15083405
• MDR Text Key: 296374188
• Report Number: 0001825034-2022-01683
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/I
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 10/04/2022
• 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
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Sex: Female