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 Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)

Event Date 09/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: catalog number:010000700 lot number: 3395124 brand name:g7 bonemaster ltd, catalog number:010000846 lot number: 3464197 brand name:g7 neutral e1 liner, catalog number:51-199334 lot number:unknown brand name:sirius hip stem 34-c, catalog number:51-199300 lot number: unknown brand name: sirius winged centralizer, catalog number:650-1163 lot number: 3377385 brand name:delta cer fem hd 32/-3mm t1.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04915, 0001825034-2019-04916, 0001825034-2019-04917, 0001825034-2019-04918.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.Device remains implanted in the patient.

Event Description

It was reported that the patient reported moderate pain, a new onset slight limp, some limitations with adls (activities of daily living), and decrease in overall satisfaction and health state scores approximately 3 years post implantation.No revision has been reported to date.Additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp) findings: 1 year follow up: o hhs 87.9, slight pain, functional activities with ease, normal gait, lld 0cm o eq5d 0.827, moderate pain, no problems performing activities, health state 100 3 year follow up: o hhs 65, moderate pain with some limitation of activity, slight limp, lld 1cm, o eq5d 0.378, moderate pain, some problems with activities, health state 30.Reported event was confirmed by review of medical records provided.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.

Event Description

No further event information available at the time of this report.

• 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
• MDR Report Key: 9266150
• MDR Text Key: 164616673
• Report Number: 0001825034-2019-04917
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: K130610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 51-199334
• Device Lot Number: 202470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 85