MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SIRIUS HIP STEM 34-C; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Loss of Range of Motion (2032)

Event Date 09/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:650-0662 lot number: 3256336 brand name: delta ceramic femoral head, catalog number:131350bm lot number:3106556 brand name: exceed ringloc shell, catalog number:ep-083650 lot number:2430446 brand name: ringloc liner.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Device remains implanted in the patient.

Event Description

It was reported that the patient experienced left hip bursitis and limited range of motion approximately 2 years post implantation.However, no revision has been reported to date, patient remains in clinical study and implanted.No further reports of bursitis or rom issues in following visits.Additional information on the reported event is unavailable.

• Brand Name: SIRIUS HIP STEM 34-C
• 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: 9177661
• MDR Text Key: 162335584
• Report Number: 0001825034-2019-04611
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 51-199334
• Device Lot Number: 216180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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 Age: 67 YR
• Patient Weight: 79