MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN IBP ULNAR STEM

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4) medical product - unknown humeral stem, therapy date - remains implanted.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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01236.

Event Description

It was reported that the patient had an initial elbow arthroplasty and subsequently the pmi group is requesting a custom device for a revision on an unknown date due to wear of the pe bearing.

Event Description

It was reported that the patient had an initial elbow arthroplasty and subsequently the pmi group is requesting a custom device for a revision on an unknown date due to wear of the pe bearing.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.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, however, the information available, supported by the opinion of the operating surgeon, suggests that implant revision was required as a consequence of normal polyethylene wear after 17 years of use.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.Product not returned.

• Brand Name: UNKNOWN IBP ULNAR STEM
• Type of Device: UNKNOWN
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8125657
• MDR Text Key: 129078648
• Report Number: 3002806535-2018-01235
• Device Sequence Number: 1
• Product Code: HSD
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1