MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN DELTA BIOLOX HEAD; UNKNOWN HIP ARTHROPLASTY

Model Number N/A

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Medical product: unknown liner, catalog #: unknown, lot #: unknown.Medical product: unknown cup, catalog #: unknown, lot #: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

A journal article was retrieved from journal of orthopaedic surgery and research (2019) that reported a retrospective comparative study from italy that looked at combined hip and knee arthroplasty in a one-stage vs a two-stage implantation.The study reviewed forty-two (42) patients enrolled into two groups: one-staged hip and knee arthroplasty (a) and two-staged hip and knee arthroplasty (b).It was reported that the study reported one patient in group a experienced a surgical wound infection within 1 month of surgery and was treated with antibiotics.*************************************************************************************************** this complaint reports the wound infection occurred within 1 month of surgery.

Event Description

A journal article was retrieved from journal of orthopaedic surgery and research (2019) that reported a retrospective comparative study from italy that looked at combined hip and knee arthroplasty in a one-stage vs a two-stage implantation.The study reviewed forty-two (42) patients enrolled into two groups: one-staged hip and knee arthroplasty (a) and two-staged hip and knee arthroplasty (b).It was reported that the study reported one patient in group a experienced a surgical wound infection within 1 month of surgery and was treated with antibiotics.This complaint reports the wound infection occurred within 1 month of surgery.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10.G3: report source, foreign - event occurred in italy.The product has not been returned to biomet for evaluation, therefore, a thorough investigation has not been possible.We have not been provided with x-rays or any supporting documentation which could provide additional information.The product and lot number identification necessary to review manufacturing history and the complaint history was not provided.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: UNKNOWN DELTA BIOLOX HEAD
• Type of Device: UNKNOWN HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10354712
• MDR Text Key: 201892679
• Report Number: 3002806535-2020-00348
• Device Sequence Number: 1
• Product Code: MEH
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• 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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other