MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR HUMERAL STEM 8 MM STEM DIAMETER 130 MM STEM LENGTH; SHOULDER PROSTHESIS/EXTREMITIES

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Arthritis (1723); Connective Tissue Disease (1786); Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00342.Medical products: item#: 00430004624, modular humeral head 24 mm head height 46 mm spherical head diameter; lot#: 61689505.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a right shoulder arthroplasty, subsequently, the patient has been indicated for a revision due to rotator cuff deficiency and glenohumeral arthritis.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00342.Medical products: item#: 00430004624, modular humeral head 24 mm head height 46 mm spherical head diameter; lot#: 61689505.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a right shoulder arthroplasty, subsequently, the patient has been indicated for a revision due to rotator cuff deficiency and glenohumeral arthritis.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the intramedullary component of the humerus is at least partially cemented with cement mantle most prominent proximally and medially.The intramedullary component is located eccentrically laterally the level of the proximal humeral diaphysis and slightly eccentrically medially at its tip.There is a thin periprosthetic lucency located medial to the cement mantle at the level of the proximal humerus.Also noted periprosthetic lucencies near the tip of the hardware component.The humeral head component is high-riding and located superior with respect to the glenoid, causing narrowing of the subacromial joint space.Besides the periprosthetic lucencies, bone quality appears relatively normal.A definitive root cause for the loosened stem noted in the mmi report cannot be determined at this time.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.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional/corrected information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00342-2.Upon receiving additional information of the reported event, it was determined to be not reportable due to disease progression evidenced by surgeons documentation of rotator cuff failure and patient's clinical signs of pain, and failure impacting patients daily activities and limiting rom.The initial report should be voided.

• Brand Name: MODULAR HUMERAL STEM 8 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: SHOULDER PROSTHESIS/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 13481323
• MDR Text Key: 285259150
• Report Number: 0001822565-2022-00343
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 00889024263789
• UDI-Public: (01)00889024263789(10)2951654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00430000813
• Device Lot Number: 61689505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female