MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER REVERSE SHOULDER REPLACEMENT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL / POLYMER CEMENTED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 11/12/2018

Event Type  Injury  

Event Description

I had a zimmer reverse shoulder replacement placed (b)(6) 2016.In (b)(6) 2017 i developed warmth in my shoulder and arm and severe pain and elevated crp and esr.I had the shoulder removed at (b)(6) clinic on (b)(6) 2018.(b)(6) performed an osteotomy and window in my humerus to remove the stem.My glenoid was broken in 3-5 pieces to remove the base.In (b)(6) 2019, xrays showed a scapula fracture.A ct scan in (b)(6) 2019 showed a huge scapula fracture caused by the removal of the shoulder.I had a 10" scapula fracture with 1-2" displacement.This required surgery and 2 plates and 23 plates were placed to pull the fracture together.Fda safety report id# (b)(4).

• Brand Name: ZIMMER REVERSE SHOULDER REPLACEMENT
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL / POLYMER CEMENTED
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 8970801
• MDR Text Key: 157128259
• Report Number: MW5089608
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 58 YR
• Patient Weight: 119