MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER GLENOID COMPONENT; PROSTHESIS, SHOULDER

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058)

Event Type  Injury  

Manufacturer Narrative

Pt identifier: - (b)(6).Wiater, j.Michael (2017) "exploring failure of total shoulder arthroplasty systems through implant retrieval, radiographic, and clinical data analyses" journal of shoulder and elbow arthroplasty, volume 1: 1¿10.Brand name: - unknown if bigliani/flatow or trabecular metal shoulder system.Initial reporter - additional journal authors - moore, drew d., moravek, james e., baker, erin a., salisbury, meagan r., baker, kevin c.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Both legacy biomet and legacy zimmer, along with competitor products, are mentioned in this journal article.It is unclear which complications are tied to what systems.Please see associated reports: 1822565-2017-04231, 1822565-2017-04385, 1822565-2017-04386, 1822565-2017-04387, 1825034-2017-04243, 1825034-2017-04244, 1825034-2017-04245, 1825034-2017-04246.

Event Description

It was reported in a journal article that nine (9) shoulder cases underwent revision for infection; two (2) shoulders for coagulase-negative staphylococci, one (1) shoulder for (b)(6), one (1) shoulder for staphylococcus, one (1) shoulder for propionibacterium, and four (4) cases that were treated and revised for infection despite having negative cultures.No further information is available.

• Brand Name: UNKNOWN ZIMMER GLENOID COMPONENT
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6663260
• MDR Text Key: 78290032
• Report Number: 0001822565-2017-04387
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention