MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN KUDO ELBOW; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problems Nerve Damage (1979); Pain (1994); Reaction (2414)

Event Date 09/20/2011

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patient mentioned in the journal article.The article was written by rotini r, bettelli g, cavaciocchi m, savarino l.This product is manufactured by zimmer biomet us and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet in (b)(4) manufactures a similar device in the united states under 510k number k972691.This report is number 1 of 2 mdrs filed for the same patient (reference 3002806535-2017-00063 / 00066).

Event Description

Patient underwent a revision of a left elbow arthroplasty due to pain and pseudotumor 16 years post-implantation.The pseudotumor caused dislocation of the ulnar nerve.This nerve was damaged during the revision and removal of the pseudotumor.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported patient underwent a revision of a left elbow arthroplasty due to pain, pseudotumor, prosthesis loosening, and wear approximately 16 years post-implantation.The pseudotumor caused dislocation of the ulnar nerve.This nerve was damaged during the revision and removal of the pseudotumor.It was further reported the patient was active and performed heavy labour with the operated arm.These conditions contributed to the failure of the device.

• Brand Name: UNKNOWN KUDO ELBOW
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6313747
• MDR Text Key: 66870580
• Report Number: 3002806535-2017-00063
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK972691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 56 YR