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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Date 11/17/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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: 3002806535-2020-00059.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 medial nerve lesion after the total elbow prosthesis.This report is based on allegations set forth in patients notice and the allegations there in are unverified.

Event Description

It was reported that the patient underwent an initial right elbow arthroplasty due to arthritis and that during this surgery the median nerve was damaged.This complaint is reporting the median nerve lesion after the total elbow prosthesis.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.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: 3002806535-2020-00059-1 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.Additionally, in the complaint description, the allegation set out from the patient is directed towards the surgeon.There is no information in the complaint to suggest the reported event is device related.For this complaint, occurrence rate cannot be calculated since as per the complaints search attached there are only 2 complaints for the item numbers in scope and both complaints are linked, with one patient and one allegation involved, therefore the occurrence cannot be based on a single event.Complaints trending will monitor similar complaints for these items and further assessment can be undertaken when required.No corrective or preventive actions are deemed necessary at this time.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: 9652290
• MDR Text Key: 177173635
• Report Number: 3002806535-2020-00060
• 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: 01/31/2020
• 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): Other
• Patient Age: 40 YR