MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X40MM ST/RST; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Material Erosion (1214); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 03/24/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a reverse shoulder arthroplasty on an unknown date.Subsequently, in an unknown timeframe post-implantation, the patient was revised due to aseptic loosening with periprosthetic osteolysis, wear of the poly component, and metallosis.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product is getting pathology tested.The investigation is in process.Once the investigation has been completed, a follow-up mir will be submitted.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.Device product code: phx.Concomitant products: part# 115370, lot 944340; part# xl-115363; lot# 798550; part# pt-113950; lot# 682270; part# 113648; lot# 647510; part# 118001; lot# 384530; part# 115310; lot# 042090; part# 180560; lot# 114970; part# 180558; lot# 330140; part# 180553; lot# 687720; part# 180553; lot# 093880; part# 115330; lot# 157840; report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00424, 0001825034 - 2022 - 00425, 0001825034 - 2022 - 00426, 0001825034 - 2022 - 00427, 0001825034 - 2022 - 00428, 0001825034 - 2022 - 00429, 0001825034 - 2022 - 00430, 0001825034 - 2022 - 00431, 0001825034 - 2022 - 00432, 0001825034 - 2022 - 00433, 0001825034 - 2022 - 00435.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information 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

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

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a4; b4; b5; g3; g6; h1; h2 upon reassessment of the reported event, it was determined to be not reportable.Metallosis caused between the articulation of the tray and glenosphere is a secondary failure of the poly wear.Loosening is also a secondary failure of poly wear.The initial report was forwarded in error and should be voided.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMP RVS CNTRL 6.5X40MM ST/RST
• 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: 13653516
• MDR Text Key: 286495740
• Report Number: 0001825034-2022-00434
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304677104
• UDI-Public: (01)00880304677104(17)250710(10)714870
• Combination Product (y/n): N
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115398
• Device Lot Number: 714870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: 03/15/2022; 06/07/2022
• Supplement Dates FDA Received: 04/11/2022; 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 48 KG