MAUDE Adverse Event Report: BIOMET UK LTD. 32MM MOD HEAD COCR +12MM NECK; PROSTHESIS, HIP

Model Number N/A

Device Problem Loss of Osseointegration (2408)

Patient Problem Unspecified Infection (1930)

Event Date 09/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported by legal the patient was revised to address multiple issues including malposition of a competitor cup, adverse local tissue reaction, prosthesis loosening at an unknown interface, infection, leg length discrepancy, and eccentric loading of the joint.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.Please note that biomet bi-metric stem, unknown femoral head and competitor's product, lubinus-cup have been implanted.The relevant instruction for use for the bi-metric stem states the following under warnings and precautions: 16.Do not use prosthetic implants from other systems with biomet components due to the probability of incompatible sizing and bearing surfaces, which may lead to premature wear, malalignment and failure.Investigation is completed based on current available information.The legal case is on-going.If any additional information becomes available, then the complaint will be reopened and investigated, and subsequently a supplemental report will be provided where deemed required.

Manufacturer Narrative

Upon receipt of additional information it has been determined that this complaint is a duplicate of (b)(4).This incident has been previously reported under mdr no: 3002806535-2014-00270.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Unique identifier udi # - (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-01003, 0001825034-2018-08651, 0001825034-2018-08650, 3002806535-2018-01047.

• Brand Name: 32MM MOD HEAD COCR +12MM NECK
• Type of Device: PROSTHESIS, HIP
• 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: 6996375
• MDR Text Key: 90887107
• Report Number: 3002806535-2017-01003
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PK911684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 163673
• Device Lot Number: 0000587055
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2010
• 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 Weight: 96