MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SRS MODULAR STEM W/ SCREW; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 211220, comprehensive segmental revision system proximal body - large, 408330, 211226, comprehensive segmental revision system intercalary segments w/ screw, 186830, 211229, comprehensive segmental revision system modular regenerex augment w/ screw, 916390.Foreign country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 - 00639, 0001825034 - 2019 - 00634, 0001825034 - 2019 - 00635.Not returned to manufacturer.

Event Description

It has been reported that patient was revised approximately six months post-implantation due to infection.No additional patient consequences were reported.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

Event Description

Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

• Brand Name: COMPREHENSIVE SRS MODULAR STEM W/ SCREW
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8340061
• MDR Text Key: 136164161
• Report Number: 0001825034-2019-00637
• 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: 04/12/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 211230
• Device Lot Number: 653070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 02/14/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 04/12/2019
• 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: 60 YR
• Patient Weight: 125