MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE PRIMARY SHOULDER MINI HUMERAL STEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

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 Fever (1858); Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Localized Skin Lesion (4542); Swelling/ Edema (4577)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4) medical product: catalog #: 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 913310.Catalog #: 115396, comp rvs cntrl 6.5x30mm st/rst, lot # 074240.Catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 586200.Catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 761260.Catalog #: ti-115313, comp vrsdl glnspr 36mm +3 ti, lot # 580230.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01549, 0001825034-2021-01551, 0001825034-2021-01552, 0001825034-2021-01553, 0001825034-2021-01554.

Event Description

It was reported that the patient underwent a right shoulder revision procedure approximately 4 years post-implantation due to pain, loss of range of motion, and loosening of the components.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event.Please see the associated reports (updated): ¿ 0001825034-2021-01549; ¿ 0001825034-2021-01551; ¿ 0001825034-2021-01552; ¿ 0001825034-2024-00891; ¿ 0001825034-2021-01553; ¿ 0001825034-2024-00892; ¿ 0001825034-2021-01554; ¿ 0001825034-2024-00893; ¿ 0001825034-2024-00894.Corrections to d1 and d2.D10: associated product information, part number (lot number): 010000589 (913310); 115396 (074240); 180553 (586200); 180553 (586200); 180551 (761260); 180551 (761260); ti-115313 (580230); 115340 (597650); xl-115363 (276000); an updated investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

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.

• Brand Name: COMPREHENSIVE PRIMARY SHOULDER MINI HUMERAL STEM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 11874263
• MDR Text Key: 252312526
• Report Number: 0001825034-2021-01555
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060692
• 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,Followup,Followup
• Report Date: 04/01/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 113627
• Device Lot Number: 161460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2012
• 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
• Treatment: H10; SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female