MAUDE Adverse Event Report: ZIMMER BIOMET, INC. +2MM LATERAL OFFSET 25MM POST LENGTH BASE PLATE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number 00434902502

Device Problems Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 the patient underwent an initial left shoulder surgery on an unknown date.Subsequently, the patient is being considered for a revision surgery due to an unknown reason.

Event Description

It was reported that a patient underwent an initial left shoulder arthroplasty approximately five and a half years ago.The patient was then revised approximately five months later for an unknown reason.Subsequently, the patient is being considered for another revision surgery on and unknown date due to the implant loosening.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.D10: item#: 01.04223.042, invers/revers scr syst 4.5-42; lot#: 2921547.Item#: 01.04223.036, invers/revers scr syst 4.5-36; lot#: 2933860.Item#: 01.04223.042, invers/revers scr syst 4.5-42; lot#: 2913746.Item#: 01.04223.036, invers/revers scr syst 4.5-36; lot#: 2929678.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 related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.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

It was reported that a patient underwent an initial left shoulder arthroplasty approximately five and a half years ago.The patient was then revised approximately five months later for an unknown reason.Subsequently, the patient is expecting to undergo a revision surgery due to the tm reverse baseplate loosening and falling out of place.

• Brand Name: +2MM LATERAL OFFSET 25MM POST LENGTH BASE PLATE
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): .; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17260141
• MDR Text Key: 318404841
• Report Number: 0001822565-2023-01801
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00889024269033
• UDI-Public: (01)00889024269033(17)270430(11)63652921
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130661
• 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: 11/02/2023

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 Catalogue Number: 00434902502
• Device Lot Number: 63652921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 08/28/2023; 11/02/2023
• Supplement Dates FDA Received: 09/12/2023; 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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): Other
• Patient Sex: Male