MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number XL-115363

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Pain (1994); Loss of Range of Motion (2032); Localized Skin Lesion (4542); Swelling/ Edema (4577)

Event Date 05/15/2019

Event Type  Injury  

Event Description

It was reported that a patient with a known history of nickel allergy underwent a conversion from a right shoulder hemiarthroplasty to a reverse total shoulder arthroplasty due to rotator cuff deficiency with capsular contracture approximately nine years (9) and three (3) months ago.After implantation, the patient continued to have range of motion concerns, pain, swelling, low fevers, and skin lesions.After a negative infection workup, the patient was found to have an allergy to vanadium.The patient underwent explantation of all components approximately four (4) years and five (5) months later.During the procedure, there were no signs of loosening or infection.An osteotomy was required to remove the well-fixed stem.Cerclage wires were placed to stabilize the osteotomy, but no shoulder implants were inserted.No complications were reported as a result of the surgery.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see the associated reports: 0001825034-2021-01549, 0001825034-2021-01551, 0001825034-2021-01552, 0001825034-2024-00891, 0001825034-2021-01553, 0001825034-2024-00892, 0001825034-2021-01554, 0001825034-2021-01555, 0001825034-2024-00893.D10: associated product information, part number (lot number): 010000589 (913310), 115396 (074240), 180553 (586200), 180553 (586200), 180551 (761260), 180551 (761260), ti-115313 (580230), 113627 (161460), 115340 (597650).The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19011282
• MDR Text Key: 339006023
• Report Number: 0001825034-2024-00894
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304475427
• UDI-Public: (01)00880304475427(17)191112(10)276000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2024

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: 11/12/2019
• Device Catalogue Number: XL-115363
• Device Lot Number: 276000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female