MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER TRABECULAR METAL REVERSE SHOULDER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pneumonia (2011)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Renfree, kevin et al.¿cost utility analysis of reverse total shoulder arthroplasty".Reference journal article attached.(2013) 22, 1656-1661.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.The article was written by kevin j.Renfree, steven j.Hattrup, and yu-hui h.Chang the complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.(b)(4).

Event Description

It was reported in a journal article that one (1) patient presented with pneumonia, that was responsible for a prolonged hospital stay of 4 days.No further information has been provided.

• Brand Name: UNKNOWN ZIMMER TRABECULAR METAL REVERSE SHOULDER
• 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: 6615617
• MDR Text Key: 76820399
• Report Number: 0001822565-2017-03888
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization