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

Catalog Number	XL-115363
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Pain (1994); Loss of Range of Motion (2032); Localized Skin Lesion (4542); Swelling/ Edema (4577)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The device evaluation found that the product did not contain the allergen vanadium and did not contribute to the serious injury; therefore, it was determined to be not reportable.The initial report should be voided.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING
• Common Device Name: 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
• Report Number: 0001825034-2024-00894
• Device Sequence Number: 11732507
• Product Code: PHX
• UDI-Device Identifier: 00880304475427
• UDI-Public: (01)00880304475427(17)191112(10)276000
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female