MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 4 1 AXLE PIN, 1 HUMERAL BEARING A, 2 ULNAR BEARINGS B; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.However, patient had a work related injury approximately 5 months prior to the reported event which may have been a contributing factor.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00577, 0001822565-2019-00579, 0001822565-2019-00058.

Event Description

It was reported that the patient suffered from post traumatic contracture of the heterotopic bone posterior to compartment.Attempts to obtain additional information have been made, however, no more is available at this time.

Event Description

It was reported that the patient underwent a left elbow contracture release and heterotopic ossification bone removal approximately sixteen (16) months post-operatively following a work-related injury that had occurred five (5) months prior.Operative notes from the contracture release and heterotopic ossification bone removal identified that the patient had extensive scarring in the anterior compartment with ectopic bone in the lateral gutter and posteriorly at the tip of the olecranon.The scarring and bone were excised and the wound thoroughly irrigated.No components were removed and the surgery was completed with the patient in stable condition with increased range of motion.

Manufacturer Narrative

Medical records were received and the reported event was confirmed.Upon review of the information received, the root cause remains undetermined as previously reported.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: ARTICULATION KIT SIZE 4 1 AXLE PIN, 1 HUMERAL BEARING A, 2 ULNAR BEARINGS B
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8695972
• MDR Text Key: 147898248
• Report Number: 0001822565-2019-02447
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00840009400
• Device Lot Number: 63386320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00840001407, ULNAR COMPONENT,63331578; 00840004410, HUMERAL COMPONENT,63418825; 00840009000, HUMERAL SCREWS,63610435; 00840001407, ULNAR COMPONENT,63331578; 00840004410, HUMERAL COMPONENT,63418825; 00840009000, HUMERAL SCREWS,63610435
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 84