MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM G; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Embolism (1829)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 110010247, g7 osseoti 4 hole shell 58mm g, lot 6470228; 12115120, cer bioloxd mod hd 36mm -3 nk, lot 2971242; 51104100, tprlc 133 t1 pps ho 10x140mm, lot 6338694.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03031 shell, 0001825034-2019-03027 head, 0001825034-2019-03032 stem.

Event Description

It was reported that the patient underwent right primary total hip replacement.Patient subsequently developed right lower extremity dvts 15 days later.Attempts were made to obtain additional information; however, none was available.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp findings: ted stockings edema lower extremity (this is a normal finding, and also can be related to dvts) doppler/ultrasound bilateral les multiple dvts found in right le (popliteal vein, femoral vein in thigh, common femoral and posterior tibial/peroneal referred to dr.Roxana cline on 25 june 2019 for anticoagulation therapy xray of right hip- good alignment/position no abnormal findings 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: G7 NEUTRAL E1 LINER 36MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8802933
• MDR Text Key: 151449102
• Report Number: 0001825034-2019-03026
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000859
• Device Lot Number: 3476195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2019
• 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: 84