MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN MODULAR HEAD COMPONENT 28MM+6MM; HIP PROSTHESIS

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem Joint Dislocation (2374)

Event Date 02/29/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products exceed abt e1 muller cup 28x56; item: ep-122856: lot: 2241124.Unknown mallory head stem 12x165mm.Foreign netherlands study clinical study ortho.Cr.Gh005.Multiple mdr reports were filed for this event, please see associated report: 3002806535 -2022 -00412.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.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

It was reported in a clinical study that the patient underwent a revision procedure approximately 1 month post implantation due to dislocation where the head was exchanged and impingement of the front left acetabulum due to osteophytes was removed.Attempts have been made and no further information has been provided.

• Brand Name: UNKNOWN MODULAR HEAD COMPONENT 28MM+6MM
• 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: 15500924
• MDR Text Key: 300761829
• Report Number: 3002806535-2022-00413
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization