MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR VIVACIT-E 36MM BRNG STD; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number 110031424

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that a patient underwent a right shoulder arthroplasty on an unknown date.Subsequently, the patient has undergone the first stage of a two-stage revision surgery where a cement spacer was implanted for an unknown reason.The patient will undergo the second stage revision surgery on an unknown date.Multiple attempts have been made to obtain additional information.There has been no additional information 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 remains implanted in the patient.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.D10: medical products: item#: 110031399, mini tray std cocr +0 offset; lot#: 64505652.Item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 867350.Item#: 115396, comp rvs cntrl 6.5x30mm st/rst; lot#: 161620.Item#: 180550, comp lk scr 3.5hex 4.75x15 st; lot#: 961090.Item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 277490.Item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 715000.Item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: 260790.Item#: 180552, comp lk scr 3.5hex 4.75x25 st; lot#: 279000.Item#: 113609, comp primary stem 9mm micro; lot#: 559790.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 a patient underwent a right shoulder arthroplasty on and unknown date.The patient then underwent a revision surgery approximately four (4) years ago for an unknown reason.Subsequently, the patient underwent the first stage of a two-stage revision surgery on an unknown date due to infection.

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 information.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.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.

• Brand Name: CR VIVACIT-E 36MM BRNG STD
• 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: 17452920
• MDR Text Key: 320348392
• Report Number: 0001822565-2023-02072
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181611
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 110031424
• Device Lot Number: 64354397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2019
• 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: SEE H10 NARRATIVE.
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female