MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD RGX AUG - SM; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problem Impaired Healing (2378)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 211222 compr srs tumor bdy - 61mm 538540; 211227 compr srs ic seg - 120mm 121650; 211230 compr srs mod stem - 6x75mm 762960; 211278 compr srs seas hmrl head 48x19 241330.Foreign - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01212; 0001825034-2019-01214; 0001825034-2019-01216; 0001825034-2019-01220.

Event Description

It was reported that a patient had comprehensive srs hemiarthroplasty placed in the right shoulder.Subsequently, the patient experienced wound drainage during staple removal two (2) weeks post implantation.The patient was treated with prophylactic antibiotics.

Event Description

Upon reassessment of the reported event based on additional information received, it was determined the event was not a complaint.Hence the initial report submitted needs to be voided.

Manufacturer Narrative

Upon reassessment of the reported event based on additional information received, it was determined the event was not a complaint.Hence the initial report submitted needs to be voided.

• Brand Name: COMPR SRS MOD RGX AUG - SM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8437339
• MDR Text Key: 139352899
• Report Number: 0001825034-2019-01215
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 211228
• Device Lot Number: 301880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 109