MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X50MM ST/RST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number 115400

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/10/2023

Event Type  Injury  

Event Description

It was reported that while the surgeon was implanting the implant during a shoulder arthroplasty, the implant fractured.The surgeon was not able to remove all of the implant and the patient retained a portion of the implant.The surgeon was able to implant a second implant.Multiple attempts have been made to obtain additional information.No response has been received at this time.

Manufacturer Narrative

(b)(4).H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that while the surgeon was implanting the implant during a shoulder arthroplasty, the implant fractured.The surgeon was not able to remove all of the implant and the patient retained a portion of the implant.The surgeon was able to implant a second implant.There are no plans to revise the patient and remove the piece of the implant that was retained in the patient's bone.

Manufacturer Narrative

(b)(4).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.

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.Medical records were not provided.The root cause of the reported issue is attributed to user-error.Per comprehensive® vault reconstruction system surgical technique and the comprehensive® reverse shoulder system surgical technique, "insert the desired length 6.5 mm central screw and completely tighten with the 3.5 mm hex driver." the central screws are to be inserted using a driver without power.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.

• Brand Name: COMP RVS CNTRL 6.5X50MM ST/RST
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17663468
• MDR Text Key: 322423347
• Report Number: 0001822565-2023-02382
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304677128
• UDI-Public: (01)00880304677128(17)320308(17)653590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2024
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 115400
• Device Lot Number: 653590
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 10/09/2023; 01/05/2024
• Supplement Dates FDA Received: 11/01/2023; 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male