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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Total hip arthroplasty after rotational acetabular osteotomy.Ito, h.; takatori, y.; moro, t.; oshima, h.; oka, h., tanaka, s.(2014) the journal of arthroplasty.Journal homepage: www.Arthroplastyjournal.Org; article history:received 21 august 2014; accepted 1 october 2014.The product was not available for return.Without the opportunity to examine the complaint device, root cause cannot be determined.Part and lot identification are necessary for review of device history records and complaint history, neither were provided.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.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

Information was received based on review of a journal article entitled, "total hip arthroplasty after rotational acetabular osteotomy".The article addresses the post-operative complication of venous thromboembolism (vte) in two (2) cases.There has been no further information provided and the patients outcome is unknown.

• Brand Name: UNKNOWN HIP
• 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: 6933768
• MDR Text Key: 89172420
• Report Number: 0001825034-2017-08287
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2017

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: UNKNOWN HIP
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 10/10/2017
• 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