MAUDE Adverse Event Report: ZIMMER, INC. INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY REGULAR RIGHT; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Material Erosion (1214); Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is unknown at this time if the device is being returned for evaluation, the investigation has been started and if the device is received, an evaluation will be performed and a follow up will be submitted.Concomitant medical products: catalog number 32810502604, lot number 62790393, interchangeable humeral assembly for cemented use only regular.Multiple mdr reports were filed for this event, please see associated reports: 1822565-2017-01747 & 01776.

Event Description

It was reported that the patient underwent a right elbow arthoplasty procedure and approximately fifteen (15) months post-implantation the articulate pin fractured.Subsequently, the patient was revised twenty-one (21) months post-implantation.Operative notes indicated 2 ml of clear synovial fluid discharged from the joint cavity, the pin was destroyed and the polyethylene insert components were worn.The pin and inserts were removed and replaced.

Manufacturer Narrative

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

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Radiographic evaluation evidenced signs of poly wear and component migration but fracture could not be confirmed.The device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.A definite root cause cannot be determined with the information provided, however, the patient doesn't deny sport activities which may have contributed to event.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.

• Brand Name: INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY REGULAR RIGHT
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6414793
• MDR Text Key: 70264097
• Report Number: 0001822565-2017-01776
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: PK001989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 32810506302
• Device Lot Number: 62774233
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2014
• 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
• Patient Age: 31 YR