MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN MOM SHELL

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported by the patient's legal representative that the patient underwent a right hip replacement procedure.Subsequently, the patient alleges undefined damages caused by unknown mom biomet implant.Elevated metal ion levels were reported.This report is based on allegations set forth in patients notice and the allegations there in are unverified.

Manufacturer Narrative

Concomitant medical products - unknown mom head.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2018-00837.

Event Description

Claim for alleged damages caused by unknown mom implant.

Manufacturer Narrative

(b)(4).The follow up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It has been reported by the patient's legal representative that the patient underwent a right hip replacement procedure and subsequently, the patient was revised due to elevated metal ion levels.This report is based on allegations set forth in patients notice and the allegations there in are unverified.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined an mdr will not have been filed under the current mfr number.This event will be reported under medwatch facility (b)(4).

• Brand Name: UNKNOWN MOM SHELL
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7531944
• MDR Text Key: 108851415
• Report Number: 3002806535-2018-00836
• Device Sequence Number: 1
• Product Code: HRY
• 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: foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 61 YR