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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 01/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This product is manufactured by zimmer biomet us and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet in warsaw, indiana manufactures a similar device in the united states under 510k number k042037.Concomitant medical products: 22-301343 arcos con sz c std 80mm ha 854650, 22-300918 arcos 18x190mm spl tpr dist ha 176110, unknown double mobility avantage cup, unknown double mobility avantage insert, 00625006515 bone screw self-tapping 6.5 mm dia.15 mm length 62566993, 00625006520 bone screw self-tapping 6.5 mm dia.20 mm length 62256199, 00625006520 bone screw self-tapping 6.5 mm dia.20 mm length 62748069 00625006540 bone screw self-tapping 6.5 mm dia.40 mm length 62440464, 11-302144 arcos lateral troch bolt 44mm 566380, 11-302102 arcos troch claw small 100mm 286710, 120002 cocr troch cable 2.0mmx750mm 008130, 120010 cocr cable/sleeve set 2.0mm 900490.The complaint cannot be confirmed since the surgical op notes were not provided.Post operative x-ray review shows the overall fit and alignment of the hardware is appropriate.Osteopenia is likely present.No signs of loosening or radiolucency.The device history records were reviewed and identified no deviations and/or anomalies that relate to the reported event.A definitive root cause cannot be established with the information 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 a right hip revision surgery.Subsequently, the patient experienced wound dehiscence.Patient was treated with debridement, cultures, and prophylactic antibiotics with in one month post implantation.No additional information is available.

• Brand Name: 32MM COCR BIOMET FEM HD +3 NK
• 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: 7855947
• MDR Text Key: 119555689
• Report Number: 3002806535-2018-01019
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 650-0873
• Device Lot Number: 3123536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2013
• 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: 76 YR
• Patient Weight: 78