MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SRS PROXIMAL BODY; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 211236, compr srs mod stem - 8 x 100 mm, unknown.Unknown, unknown glenosphere, unknown.Unknown, unknown humeral tray, unknown.Unknown, unknown humeral bearing, unknown.Unknown, unknown baseplate, unknown.Unknown, unknown central screw, unknown.Unknown, unknown peripheral screw, unknown.(b)(6).Reported event was unable to be confirmed as lot number of device involved in the incident is unknown.Provided patient x-rays were reviewed with no product problem identified.Overall fit and alignment of the reverse arthroplasty is appropriate.No signs of loosening or radiolucency.Bony fragment along the medial aspect of the proximal humeral diaphysis and superior within the joint space which could represent heterotopic ossification, which can be a source of pain.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 could not be determined with information available.A contributing factor to the pain could be the heterotopic ossification noted in the x-ray review.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.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01300, 0001825034-2018-03963, 0001825034-2018-03964, 0001825034-2018-03965, 0001825034-2018-03966, 0001825034-2018-03967, 0001825034-2018-03968.

Event Description

It was reported that a patient underwent a revision shoulder procedure.During a six month follow up, the patient reported experiencing moderate pain.The quickdash questionnaire taken at the six month follow-up also revealed that the patient was experiencing moderate difficulty opening a tight jar, performing heaving household chores, and was unable to carry a shopping bag and wash back.Severe arm, shoulder, and hand pain was also reported.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: COMPREHENSIVE SRS PROXIMAL BODY
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7593155
• MDR Text Key: 110805431
• Report Number: 0001825034-2018-01299
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK11746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 211215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2017
• 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): Other
• Patient Age: 62 YR
• Patient Weight: 79