MAUDE Adverse Event Report: BIOMET UK LTD. UNK BIOLOX DELTA CERAMIC HEAD; HIP PROTHESIS

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report: customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Part #unknown / unknown liner/ lot # unknown - reported by medwatch facility (b)(4) biomet ¿ 0001825034.

Event Description

It was reported patient underwent hip surgery approximately 5 years ago and was revised in the same year due to instability subsequently patient underwent closed reduction and additional revision due to instability and dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.

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.D11: medical product: unknown g7 liner, catalog #: unknown , lot #: unknown as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database could not be performed as item number is unavailable.Without the opportunity to examine the complaint product, the 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, the root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.Corrective action taken no corrective action required at this time.Preventive action taken no preventive action required at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported patient underwent hip surgery approximately 5 years ago and was revised in the same year due to instability.Subsequently patient underwent closed reduction and additional revision due to instability and dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNK BIOLOX DELTA CERAMIC HEAD
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10009433
• MDR Text Key: 194337687
• Report Number: 3002806535-2020-00235
• Device Sequence Number: 1
• Product Code: LZO
• 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,study
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK BIOLOX DELTA CERAMIC HEAD
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention