MAUDE Adverse Event Report: BIOMET UK LTD. IBP ULNA RIGHT SM INTLK; ELBOW PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Failure to Anastomose (1028); Arthritis (1723); Neurological Deficit/Dysfunction (1982)

Event Date 09/12/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.Concomitant medical products: medical product: ibp hmrl right sm por, catalog #: 114327, lot #: 1131588.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00057.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right elbow arthroplasty due to arthritis.During surgery, the medial nerve was severed.Subsequently, revision surgery was performed due to neurolysis and anastomosis of the median nerve.This surgery is reported to have been unsuccessful.This complaint is reporting the revision due to neurolysis and anastomosis.

Event Description

It was reported that a patient underwent an initial right elbow arthroplasty due to arthritis.During surgery, the medial nerve was severed.Subsequently, revision surgery was performed due to neurolysis and anastomosis of the medial nerve.This surgery is reported to have been unsuccessful.The patient¿s claim is directed against the surgeon.Therefore, legal will not investigate the matter.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in germany.D11: medical product: ibp hmrl right sm por, catalog #: 114327, lot #: 1131588.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00057-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.The mhr related to item 114370 has been reviewed and does not show any non-conformity, rejection or concession that could be related to the reported event.A review of the complaint database over the last 3 years has found no similar complaints found for item 114370 other than the linked complaint for same patient.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk table could not be selected for comparison.Given the information in the complaint: the hazards have a severity of 4 which is described in the risk file as: catastrophic - mechanical failure resulting in total loss of function; failure of procedure necessitating immediate revision or further procedure; total loss of patient activity or function; severe or chronic pain; injury to user or theatre staff; severe tissue reaction from materials or wear / corrosion products; loss of sterility.The outcome of the reported event therefore is in line with the rmf.However, there is no information in the complaint to suggest the reported event is device related.This complaint (revision due to neurolysis of median nerve) is an outcome of the event reported in (b)(4) (median nerve lesion after elbow tep).In order to calculate the occurrence rate, sales and complaint data for this item number have been obtained, and are attached for a period of the last 3 calendar years prior to event date, being sept 2011.For item: 114370 lot: 1145890.Sales (sept 2008 to sept 2011) = 45 units (see section 4.3.3.C of attached mir report).Complaints search was conducted for events occurring between sept 2008 to sept 2011 for item 114370.2 complaints were identified for this item number including (b)(4).Therefore, the calculated occurrence rate is 2 in 45 or 4.44%.This is above the estimated occurrence rate as per the rmf which estimates an acceptable occurrence rate of 1 (<10-6).(4.44% is considered an occurrence score of 5 (frequent) : 10-3).Since the occurrence calculation is based on only 2 complaints from a single patient, the current occurrence ratings in the risk management file are still relevant and have not been exceeded; as it is not possible to make a calculation based one patient.The failure mode will be monitored through zimmer biomet internal complaint and post market surveillance activities with further review of risk conducted through these processes.No corrective or preventive actions are deemed necessary.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: IBP ULNA RIGHT SM INTLK
• Type of Device: ELBOW PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9646307
• MDR Text Key: 176935006
• Report Number: 3002806535-2020-00058
• Device Sequence Number: 1
• Product Code: KWI
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 114370
• Device Lot Number: 1145890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2020
• 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: 41 YR