MAUDE Adverse Event Report: BIOMET UK LTD. TPRLC LAT POR FMRL 12.5X145; HIP PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Jorg schilcher, phd, md , ingemar ivarsson, phd, md, rico perlbach, md and lars palm, phd, md(2016), no difference in periprosthetic bone loss and fixation between a standard-length stem and a shorter version in cementless total hip arthroplasty.A randomized controlled trial, 1220-1226.Http://www.Sciencedirect.Com/science/article/pii/s0883540316308154?via%3dihub.(b)(4).(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-01231, 3002806535-2017-01232 - attachment: [journal article (b)(4).Pdf].

Event Description

It has been reported that a patient underwent a left hip replacement on (b)(6) 2013.Subsequently, the patient developed a deep vein thrombosis 4 weeks after the index procedure.

• Brand Name: TPRLC LAT POR FMRL 12.5X145
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7141965
• MDR Text Key: 95609315
• Report Number: 3002806535-2017-01233
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PK030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2017

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 Expiration Date: 10/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 103809
• Device Lot Number: 2508779
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 187