MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 CEMENTLESS FEM SZ L; OXFORD CEMENTLESS FEMORALS

Catalog Number 154927

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 06/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product - oxf uni cmntls tib sz f lm, item 166580, lot 1256028, therapy date - device remains implanted.Concomitant medical product - oxf anat brg lt lg size 4 pma, item 159555, lot 1220227, therapy date - device remains implanted report source, foreign - event occurred in (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01147 and 3002806535-2018-01149.

Event Description

Patient died and cause of death is unknown.To the best of our knowledge the implants remained in situ at the date of death.

• Brand Name: OXFORD PH3 CEMENTLESS FEM SZ L
• Type of Device: OXFORD CEMENTLESS FEMORALS
• 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: 7998924
• MDR Text Key: 124807816
• Report Number: 3002806535-2018-01148
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2018

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 Catalogue Number: 154927
• Device Lot Number: 918778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/24/2018
• 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 Age: 80 YR
• Patient Weight: 94