MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM A +3MM OFFSET POLY LINER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number 00-4349-036-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Muscle Hypotonia (4531); Muscle/Tendon Damage (4532)

Event Date 08/20/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent radiographic imaging, approximately one (1) year post-operatively and a stress fracture of the greater tuberosity stem was discovered on imaging.The patient was prescribed tylenol three.Approximately six (6) months after the fracture was discovered, the patient underwent a right shoulder revision surgery due to acute onset of pain and increased difficulty performing daily activities.The poly was revised and a pectoralis major repair was performed.The surgeon noted the patient displayed muscle atrophy to surrounding tissues.No further information has been reported.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02701.Concomitant medical products: item#: 00434901213, 12mm a 130mm length humeral stem; lot#: 62248463.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay corrected information.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

It was reported that revision of the implant is standard and does not indicate device problem.

• Brand Name: 36MM A +3MM OFFSET POLY LINER
• 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: 15433042
• MDR Text Key: 300028581
• Report Number: 0001822565-2022-02674
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024633063
• UDI-Public: (01)00889024633063(17)200731(10)62114032
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 00-4349-036-03
• Device Catalogue Number: 00434903603
• Device Lot Number: 62114032
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2012
• 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 Sex: Male
• Patient Weight: 78 KG