MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY SMALL RIGHT; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number 32810505302

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: medwatch filed.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Device evaluated by mfr: not returned to manufacturer.

Event Description

It was reported the patient was revised due to unknown reasons.No further information is available at this time.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

(b)(4).No device was returned for examination.Review of the device history records identified no deviations or anomalies during manufacturing that would have contributed to the reported event.No further investigative inputs were provided.The patient had multiple surgeries and it is unknown if the reported ulnar and humeral components are used at same time.A definitive root cause cannot be determined as the complication is unknown.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 SMALL RIGHT
• Type of Device: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8455328
• MDR Text Key: 139972669
• Report Number: 0001822565-2019-01247
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K883665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 32810505302
• Device Lot Number: 61971269
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 07/23/2019
• 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: 73 YR