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

Model Number N/A

Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 06/06/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical devices: unknown liner; item# unknown; lot# unknown.G2 - foreign: poland.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00217.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : product is unknown.

Event Description

It was reported that patient underwent a total hip arthroplasty and approximately 3 years later a revision surgery was performed due to dislocation and loosening of the liner.Attempts have been made and no further information has been provided.

Event Description

It was reported that patient underwent a total hip arthroplasty and approximately 3 years later a revision surgery was performed due to dislocation of the head and wear of the liner.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.D10 - medical devices: e1: tapered std +3mm lnr 32/39; item#: e1-003239; lot#: unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified that the shell and liner have excessive wear as a result of the dislocated head/stem impinging on the edge of the liner and shell.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical radiographs were provided and reviewed by a radiologist: there is superior position of the prosthetic femoral head reflecting severe polyethylene liner wear or displacement.There is no implant loosening or other abnormality.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN 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: 17296955
• MDR Text Key: 318750328
• Report Number: 3002806535-2023-00218
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN HEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/13/2023; 09/07/2023
• Supplement Dates FDA Received: 07/27/2023; 09/07/2023
• 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): Required Intervention; Hospitalization