MAUDE Adverse Event Report: BIOMET UK LTD 32MM MOD HD COCR +3MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Insufficient Information (3190); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.(b)(4).There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 14 states, ¿postoperative bone fracture and pain.¿.

Event Description

It was reported that patient underwent right total hip arthroplasty on (b)(6) 2015.Subsequently, patient experienced occasional pain and noise from the hip.No further information has been provided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.This will be reported on 3002806535-2016-00049.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch.Upon further review, the report will be submitted under a us mfr.Other text : remains implanted.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: 32MM MOD HD COCR +3MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD; waterton industrial estate; bridgend IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5333094
• MDR Text Key: 34645209
• Report Number: 0001825034-2015-05210
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK911684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/20/2016

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 163670
• Device Lot Number: 00J3402288
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: 05/20/2016; 05/20/2016; 05/20/2016
• Supplement Dates FDA Received: 02/02/2016; 05/19/2016; 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2015
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 88