MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 36MM -3 NK; HIP PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: g7 neutral e1 liner 36mm g catalog #: 010000859 lot #: 3476195, medical product: g7 osseoti 4 hole shell 58mm g catalog #: 110010247 lot #: 6470228, medical product: tprlc 133 t1 pps ho 10x140mm catalog #: 51-104100 lot #: 6338694.Remains implanted.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent right primary tha.Patient subsequently developed right lower extremity deep vein thrombosis and referred to anticoagulant specialist to treat.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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.

Event Description

It was reported that the patient underwent right primary tha.Patient subsequently developed right lower extremity deep vein thrombosis and referred to anticoagulant specialist to treat.

• Brand Name: CER BIOLOXD MOD HD 36MM -3 NK
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9103763
• MDR Text Key: 159587556
• Report Number: 3002806535-2019-00763
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

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: 12-115120
• Device Lot Number: 2971242
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization
• Patient Weight: 84