MAUDE Adverse Event Report: BIOMET UK LTD. BIO-MOD HUM STEM 12MM; BIO-MODULAR SHOULDER SYSTEM

Catalog Number 113708

Device Problem Insufficient Information (3190)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product - not sdr hm hd 48x20 o/st without pin, item: 106516, lot: 589855.Therapy date - remains implanted.Report source, foreign - event occurred in the (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01166.

Event Description

It was reported that a patient underwent an initial left shoulder arthroplasty.Subsequently, a revision procedure is being planned due to patient's native glenoid cavity wear.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient underwent an initial left shoulder arthroplasty.Subsequently, a revision procedure was performed due to patient's native glenoid cavity wear.

Event Description

It was reported that a patient underwent an initial left shoulder arthroplasty.Subsequently, a revision procedure is being planned due to patient's naitive glenoid cavity wear.

Manufacturer Narrative

(b)(4).Device history record (dhr) was reviewed and no discrepancies were found.In order to investigate the matter thoroughly access is needed to certain hospital notes, x-rays and retrievals.Due to insufficient information provided by the hospital, the definite root cause cannot be determined, however information provided from the sales rep suggests that the reported event was due to patient condition.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.

• Brand Name: BIO-MOD HUM STEM 12MM
• Type of Device: BIO-MODULAR SHOULDER SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8020956
• MDR Text Key: 125534918
• Report Number: 3002806535-2018-01167
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K030710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 113708
• Device Lot Number: 625045
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2019
• 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
• Patient Age: 71 YR