MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14; HIP PROTHESIS

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Associated products: medical product: liner neutral 32 mm i.D.Size ii for use with 52 mm o.D.Size ii shell.Catalog #: 00875101032 lot #: 62650655.Reported by medwatch facility warsaw biomet ¿ 0001825034.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported by legal that the patient underwent an initial hip arthroplasty.Subsequently, the head and liner were revised due to instability, limb length discrepancy, reactive tissue.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, 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 over the last 3 years has found no similar complaints found for the item 00877503201.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported by legal that the patient underwent an initial hip arthroplasty.Subsequently, the head and liner were revised due to instability, limb length discrepancy, reactive tissue.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9841295
• MDR Text Key: 187594204
• Report Number: 3002806535-2020-00145
• Device Sequence Number: 1
• Product Code: LPH
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

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 Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00877503201
• Device Lot Number: 2720466
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 04/22/2020
• Supplement Dates FDA Received: 04/23/2020
• 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