MAUDE Adverse Event Report: ZIMMER BIOMET, INC. C/M HUMERAL ELBOW STEM; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Reaction (2414)

Event Date 05/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign country: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that patient was revised after unknown duration of initial surgery due to fracture of the humeral stem, loosening, metallosis and pain.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of complaint sample and photographs.Visual examination of the returned product identified that the humeral stem exhibits wear, and that the etched lot number is worn off.Inner pin has 4 prongs fractured off.Only 3 of the 4 prongs were returned.Unknown bushings were returned and are severely worn.Visual examination of the provided pictures identified black tissue in the joint which is consistent with metallosis.Fracture surface analysis performed by sem 1907-018 on the c/m inner pin sample showed that its four prongs fractured due to fatigue.Device history record (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.A summary of the investigation has been sent to the complainant.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.

Event Description

It has been reported that patient was revised approximately 10 years post-implantation due to fracture of the humeral stem, loosening, metallosis and pain.No additional patient consequences were reported.

• Brand Name: C/M HUMERAL ELBOW STEM
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8664814
• MDR Text Key: 146891591
• Report Number: 0001822565-2019-02295
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K001989
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32810502606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN ULNAR
• Patient Outcome(s): Hospitalization; Required Intervention