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

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information: concomitant medical products: device name: unknown liner, model: unknown, lot: unknown.This is a combined initial / final report is being submitted to relay additional information.The product will not be returned to zimmer biomet for investigation, as it remains implanted.Occupation: author/md.Foreign report source: (b)(6).The product has not been returned to biomet uk ltd for evaluation, therefore, a thorough investigation has not been possible.Attempts were made to obtain additional information.However no response was received from journal article author.We have not been provided with x-rays or any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Trend analysis could not be performed as product numbers are not available.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.

Event Description

It was reported that the study reported two post-traumatic hip dislocations occurred at 6 and 8 months after surgery that were reduced in er and managed with brace for 1-month without need for revision of implants in group b.Attempts were made to obtain additional information.However no response was received from journal article author.

• 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
• 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: 10288572
• MDR Text Key: 199273065
• Report Number: 3002806535-2020-00323
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/17/2020

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 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
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other