MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN FEMORAL HEAD; HIP PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Report source, foreign - event occurred in (b)(6).Medical product - unknown bi-metric collared stem, therapy date - unknown.Medical product - unknown pfu shell (competitor product), therapy date - unknown.Medical product - unknown liner (competitor product), therapy date - unknown.Hughes r.E., batra a., hallstrom b.R.(2017) "arthroplasty registries around the world: valuable sources of hip implant revision risk data.", current reviews musculoskeletal medicine (2017) 10:240¿252, https://www.Ncbi.Nlm.Nih.Gov/pmc/articles/pmc5435639/ the purpose of this paper is to briefly describe arthroplasty registry concepts, international registries around the world, us registries, and provide a parsimonious summary of total hip arthroplasty (tha) implant revision risk reports across registries.The product and lot number identification necessary to review manufacturing history and the complaint history was not provided.Current information is insufficient to permit conclusion as to the cause of the event.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-01114.

Event Description

It has been reported in a journal article that 653 bi-metric collared stem (uncemented implants) revisions from the (b)(6) national joint registry for the past 10 years.Attempts have been made to retrieve additional information on the reported events, however no information has been made available.

• Brand Name: UNKNOWN FEMORAL HEAD
• Type of Device: HIP PROSTHESIS
• 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: 7056765
• MDR Text Key: 92835603
• Report Number: 3002806535-2017-01115
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention